## Protocol Section
### Identification Module
**NCT ID:** NCT00661479

**Brief Title:** An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa

#### Organization Study ID Info
**ID:** 190342-028D
#### Organization
**Class:** INDUSTRY
**Full Name:** Allergan
### Status Module
#### Completion Date
**Date:** 2010-05

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2011-02-09

**Type:** ESTIMATED

**Disp First Submit Date:** 2011-02-02
**Disp First Submit QC Date:** 2011-02-02

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-04-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-03-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2013-04-24

**Type:** ESTIMATED

**Results First Submit Date:** 2013-03-13

**Results First Submit QC Date:** 2013-03-13

#### Start Date
**Date:** 2008-07

**Status Verified Date:** 2013-03

#### Study First Post Date
**Date:** 2008-04-18
**Type:** ESTIMATED
**Study First Submit Date:** 2007-10-29
**Study First Submit QC Date:** 2008-04-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Allergan

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.

### Conditions Module

**Conditions:**

- Retinitis Pigmentosa

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 21

**Type:** ACTUAL

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

**Intervention Names:**

- Drug: 400 µg Brimonidine Tartrate Implant

- Other: Sham (no implant)

**Label:** 400 µg Brimonidine Tartrate Implant Group B

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

**Intervention Names:**

- Drug: 200 µg Brimonidine Tartrate Implant

- Other: Sham (no implant)

**Label:** 200 µg Brimonidine Tartrate Implant Group B

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

**Intervention Names:**

- Drug: 100 µg Brimonidine Tartrate Implant

- Other: Sham (no implant)

**Label:** 100 µg Brimonidine Tartrate Implant Group B

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

**Intervention Names:**

- Drug: 100 µg Brimonidine Tartrate Implant

- Other: Sham (no implant)

**Label:** 100 µg Brimonidine Tartrate Implant Group A

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 400 µg Brimonidine Tartrate Implant Group B

**Description:** 400 µg brimonidine tartrate implant in the study eye on Day 1.

**Name:** 400 µg Brimonidine Tartrate Implant

**Other Names:**

- Brimonidine Tartrate PS DDS®

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 200 µg Brimonidine Tartrate Implant Group B

**Description:** 200 µg brimonidine tartrate implant in the study eye on Day 1.

**Name:** 200 µg Brimonidine Tartrate Implant

**Other Names:**

- Brimonidine Tartrate PS DDS®

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- 100 µg Brimonidine Tartrate Implant Group A

- 100 µg Brimonidine Tartrate Implant Group B

**Description:** 100 µg brimonidine tartrate implant in the study eye on Day 1.

**Name:** 100 µg Brimonidine Tartrate Implant

**Other Names:**

- Brimonidine Tartrate PS DDS®

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- 100 µg Brimonidine Tartrate Implant Group A

- 100 µg Brimonidine Tartrate Implant Group B

- 200 µg Brimonidine Tartrate Implant Group B

- 400 µg Brimonidine Tartrate Implant Group B

**Description:** Sham in the fellow eye on Day 1.

**Name:** Sham (no implant)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.

**Measure:** Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

**Time Frame:** Baseline, Month 6

#### Secondary Outcomes

**Description:** Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.

**Measure:** Change From Baseline in Contrast Sensitivity in the Study Eye

**Time Frame:** Baseline, Month 6

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Retinitis Pigmentosa in both eyes
* Visual acuity between 20/40 to count fingers

Exclusion Criteria:

* Growth of new blood vessels in the eye
* Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1
* Any ocular disease that can interfere with diagnosis and or assessment of disease progression
* Significant near-sightedness
* HIV
* Female patients who are pregnant, nursing, or planning pregnancy

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Arlington

**Country:** United States

**State:** Texas

**Location 2:**

**City:** Paris

**Country:** France

**Location 3:**

**City:** Tubingen

**Country:** Germany

**Location 4:**

**City:** Coimbra

**Country:** Portugal

#### Overall Officials

**Official 1:**

**Affiliation:** Allergan

**Name:** Medical Director

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012164

- Term: Retinal Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000015785

- Term: Eye Diseases, Hereditary

- ID: D000058499

- Term: Retinal Dystrophies

- ID: D000012162

- Term: Retinal Degeneration

- ID: D000030342

- Term: Genetic Diseases, Inborn

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15008

- Name: Retinitis

- Relevance: HIGH

- As Found: Retinitis

- ID: M15009

- Name: Retinitis Pigmentosa

- Relevance: HIGH

- As Found: Retinitis Pigmentosa

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18339

- Name: Eye Diseases, Hereditary

- Relevance: LOW

- As Found: Unknown

- ID: M29107

- Name: Retinal Dystrophies

- Relevance: LOW

- As Found: Unknown

- ID: M14997

- Name: Retinal Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: T4945

- Name: Retinitis Pigmentosa

- Relevance: HIGH

- As Found: Retinitis Pigmentosa

### Condition Browse Module - Meshes

- ID: D000012173

- Term: Retinitis

- ID: D000012174

- Term: Retinitis Pigmentosa

### Intervention Browse Module - Ancestors

- ID: D000000959

- Term: Antihypertensive Agents

- ID: D000058647

- Term: Adrenergic alpha-2 Receptor Agonists

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M265

- Name: Brimonidine Tartrate

- Relevance: HIGH

- As Found: 1.4

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068438

- Term: Brimonidine Tartrate

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.

#### Event Groups

**Group ID:** EG000

**Title:** 400 µg Brimonidine Tartrate Implant Group B

**Description:** 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

**ID:** EG000

**Other Num Affected:** 11

**Other Num at Risk:** 12

**Serious Number Affected:** 1

**Serious Number At Risk:** 12

**Title:** 400 µg Brimonidine Tartrate Implant Group B

**Group ID:** EG001

**Title:** 200 µg Brimonidine Tartrate Implant Group B

**Description:** 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

**ID:** EG001

**Other Num Affected:** 3

**Other Num at Risk:** 3

**Serious Number At Risk:** 3

**Title:** 200 µg Brimonidine Tartrate Implant Group B

**Group ID:** EG002

**Title:** 100 µg Brimonidine Tartrate Implant Groups A and B

**Description:** 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

**ID:** EG002

**Other Num Affected:** 6

**Other Num at Risk:** 6

**Serious Number Affected:** 1

**Serious Number At Risk:** 6

**Title:** 100 µg Brimonidine Tartrate Implant Groups A and B

**Frequency Threshold:** 5

#### Other Events

**Term:** Conjunctival Haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Conjunctival Hyperaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Foreign Body Sensation in Eyes

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Ocular Discomfort

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 10.0

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Glare

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Eye Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Conjunctival Oedema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Abdominal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Abdominal Pain Upper

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Anxiety

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Bite

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 10.0

**Term:** Colour Blindness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Congenital, familial and genetic disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Conjunctivitis Allergic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Dehydration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Dermatitis Allergic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Dizziness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Dry Eye

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Epididymitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Eye Irritation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Foot Fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 10.0

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Insomnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Lacrimation Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Ligament Injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 10.0

**Term:** Myalgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Neuropathy Peripheral

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Orthostatic Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Pharyngolaryngeal Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Rhinitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 10.0

**Term:** Syncope

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Tinnitus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Vision Blurred

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Wound

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 10.0

**Term:** Visual Disturbance

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Abnormal Sensation in Eye

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Bacteriuria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 10.0

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 10.0

**Term:** Ear Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Gastritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Influenza Like Illness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Keratitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Muscle Contracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Myelitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Osteoarthritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Prostate Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 10.0

**Term:** Renal Injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 10.0

**Term:** Restless Legs Syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Rhinitis Allergic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Tendonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Urinary Tract Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 10.0

**Term:** Visual Acuity Reduced

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Vitreous Floaters

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Conjunctivitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Dental Caries

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 10.0

**Term:** Pharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 10.0

#### Serious Events

**Term:** Syncope

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 12

**Group ID:** EG001

**Num At Risk:** 3

**Group ID:** EG002

**Num At Risk:** 6

**Term:** Myelitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 10.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 12

**Group ID:** EG001

**Num At Risk:** 3

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 6

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 12

**Group ID:** BG001

**Value:** 3

**Group ID:** BG002

**Value:** 3

**Group ID:** BG003

**Value:** 3

**Group ID:** BG004

**Value:** 21

**Units:** Participants

### Group

**ID:** BG000

**Title:** 400 µg Brimonidine Tartrate Implant Group B

**Description:** 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

### Group

**ID:** BG001

**Title:** 200 µg Brimonidine Tartrate Implant Group B

**Description:** 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

### Group

**ID:** BG002

**Title:** 100 µg Brimonidine Tartrate Implant Group B

**Description:** 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

### Group

**ID:** BG003

**Title:** 100 µg Brimonidine Tartrate Implant Group A

**Description:** 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

### Group

**ID:** BG004

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 18.70

**Value:** 46.3

#### Measurement

**Group ID:** BG001

**Spread:** 6.03

**Value:** 56.3

#### Measurement

**Group ID:** BG002

**Spread:** 4.04

**Value:** 48.7

#### Measurement

**Group ID:** BG003

**Spread:** 5.29

**Value:** 69.0

#### Measurement

**Group ID:** BG004

**Spread:** 16.36

**Value:** 51.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 9

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 3

#### Measurement

**Group ID:** BG004

**Value:** 12

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** clinicaltrials@allergan.com
**Organization:** Allergan, Inc
**Phone:** 714-246-4500
**Title:** Therapeutic Area Head,
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 14.61
- **Upper Limit:** 
- **Value:** 48.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 14.18
- **Upper Limit:** 
- **Value:** 51.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 3.79
- **Upper Limit:** 
- **Value:** 52.7
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 3.46
- **Upper Limit:** 
- **Value:** 4.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.41
- **Upper Limit:** 
- **Value:** 3.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.04
- **Upper Limit:** 
- **Value:** -1.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 8.50
- **Upper Limit:** 
- **Value:** 3.3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 3.79
- **Upper Limit:** 
- **Value:** 0.3
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.48
- **Upper Limit:** 
- **Value:** 15.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.21
- **Upper Limit:** 
- **Value:** 18.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.53
- **Upper Limit:** 
- **Value:** 22.3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 3.46
- **Upper Limit:** 
- **Value:** 3.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.86
- **Upper Limit:** 
- **Value:** 0.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.86
- **Upper Limit:** 
- **Value:** -0.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.15
- **Upper Limit:** 
- **Value:** 4.3
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 1.73
- **Upper Limit:** 
- **Value:** -2.0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Safety Population: all patients treated on Day 1
**Reporting Status:** POSTED
**Time Frame:** Baseline, Month 6
**Title:** Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
**Type:** PRIMARY
**Unit of Measure:** Number of Letters Read Correctly
##### Group
**Description:** 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
**ID:** OG000
**Title:** 400 µg Brimonidine Tartrate Implant Group B
##### Group
**Description:** 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
**ID:** OG001
**Title:** 200 µg Brimonidine Tartrate Implant Group B
##### Group
**Description:** 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
**ID:** OG002
**Title:** 100 µg Brimonidine Tartrate Implant Group B
##### Group
**Description:** 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
**ID:** OG003
**Title:** 100 µg Brimonidine Tartrate Implant Group A
#### Outcome Measure 2
**Description:** Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Safety Population: all patients treated on Day 1
**Reporting Status:** POSTED
**Time Frame:** Baseline, Month 6
**Title:** Change From Baseline in Contrast Sensitivity in the Study Eye
**Type:** SECONDARY
**Unit of Measure:** Number of Letters Read Correctly
##### Group
**Description:** 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
**ID:** OG000
**Title:** 400 µg Brimonidine Tartrate Implant Group B
##### Group
**Description:** 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
**ID:** OG001
**Title:** 200 µg Brimonidine Tartrate Implant Group B
##### Group
**Description:** 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
**ID:** OG002
**Title:** 100 µg Brimonidine Tartrate Implant Group B
##### Group
**Description:** 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
**ID:** OG003
**Title:** 100 µg Brimonidine Tartrate Implant Group A
### Participant Flow Module
#### Group
**Description:** 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
**ID:** FG000
**Title:** 400 µg Brimonidine Tartrate Implant Group B
#### Group
**Description:** 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
**ID:** FG001
**Title:** 200 µg Brimonidine Tartrate Implant Group B
#### Group
**Description:** 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
**ID:** FG002
**Title:** 100 µg Brimonidine Tartrate Implant Group B
#### Group
**Description:** 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
**ID:** FG003
**Title:** 100 µg Brimonidine Tartrate Implant Group A
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
**Pre-Assignment Details:** Patients were stratified by Best Corrected Visual Acuity (BCVA). Patients assigned to Group A had a BCVA of 20/320. Patients assigned to Group B had a BCVA worse than 20/40 and better than 20/320. Patients in Group A were randomized and treated prior to initiating enrollment in Group B. No patients from Group A participated in Group B.
**Has Results:** True