## Protocol Section
### Identification Module
**NCT ID:** NCT00300079

**Brief Title:** Study of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension

**Official Title:** A Multiple-Dose Study of the IOP-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% When Added to a PGA as Adjunctive Therapy Over a 24 Hour Period in Patients With Glaucoma or Ocular Hypertension

#### Organization Study ID Info
**ID:** CM-05-13
#### Organization
**Class:** INDUSTRY
**Full Name:** Alcon Research
#### Secondary ID Infos
**ID:** CM-05-13
### Status Module
#### Completion Date
**Date:** 2007-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-11-18

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-11-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-09

**Type:** ACTUAL

#### Start Date
**Date:** 2006-09

**Status Verified Date:** 2008-06

#### Study First Post Date
**Date:** 2006-03-08
**Type:** ESTIMATED
**Study First Submit Date:** 2006-03-06
**Study First Submit QC Date:** 2006-03-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of California, San Diego

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Alcon Research

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This is a multiple-dose study of the IOP-lowering efficacy of Azopt (brinzolamide) 1.0% compared to timolol 0.5% when added to a prostaglandin analogue (PGA) as adjunctive therapy over a 24 hour period in patients with glaucoma or ocular hypertension.

### Conditions Module

**Conditions:**

- Primary Open Angle Glaucoma

- Ocular Hypertension

**Keywords:**

- Ocular Hypertension Patients

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** brinzolamide 1.0%

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** IOP-lowering at 8 and 16 weeks

#### Secondary Outcomes

**Measure:** Safety throughout the 16 weeks of the study

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Primary open angle glaucoma or ocular hypertension patients

Exclusion Criteria:

* Women of childbearing potential
* History of bronchial asthma, or severe chronic obstructive pulmonary disease
* Presence of acute glaucoma

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Diego

**Country:** United States

**State:** California

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, San Diego

**Name:** John Liu, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Liu JH, Medeiros FA, Slight JR, Weinreb RN. Comparing diurnal and nocturnal effects of brinzolamide and timolol on intraocular pressure in patients receiving latanoprost monotherapy. Ophthalmology. 2009 Mar;116(3):449-54. doi: 10.1016/j.ophtha.2008.09.054. Epub 2009 Jan 20.

**PMID:** 19157559

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M9013

- Name: Glaucoma

- Relevance: HIGH

- As Found: Glaucoma

- ID: M9014

- Name: Glaucoma, Open-Angle

- Relevance: HIGH

- As Found: Primary Open Angle Glaucoma

- ID: M12731

- Name: Ocular Hypertension

- Relevance: HIGH

- As Found: Ocular Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005901

- Term: Glaucoma

- ID: D000005902

- Term: Glaucoma, Open-Angle

- ID: D000009798

- Term: Ocular Hypertension

- ID: D000006973

- Term: Hypertension

### Intervention Browse Module - Ancestors

- ID: D000002257

- Term: Carbonic Anhydrase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M16757

- Name: Timolol

- Relevance: LOW

- As Found: Unknown

- ID: M242996

- Name: Brinzolamide

- Relevance: HIGH

- As Found: Tri-

- ID: M5515

- Name: Carbonic Anhydrase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000111827

- Term: Brinzolamide

### Misc Info Module

- Version Holder: 2024-05-24
