## Protocol Section
### Identification Module
**NCT ID:** NCT00885079

**Brief Title:** Confirmatory Study of OPC-12759 Ophthalmic Suspension

**Official Title:** Confirmatory Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

#### Organization Study ID Info
**ID:** 037E-08-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Otsuka Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2010-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-12-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-11-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-03

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2013-12-12

**Type:** ESTIMATED

**Results First Submit Date:** 2013-09-12

**Results First Submit QC Date:** 2013-11-18

#### Start Date
**Date:** 2009-05

**Status Verified Date:** 2013-11

#### Study First Post Date
**Date:** 2009-04-21
**Type:** ESTIMATED
**Study First Submit Date:** 2009-04-19
**Study First Submit QC Date:** 2009-04-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Otsuka Pharmaceutical Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.

### Conditions Module

**Conditions:**

- Dry Eye Syndromes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 188

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Instillation,4 times/day for 4 weeks

**Intervention Names:**

- Drug: OPC-12759 Ophthalmic suspension

**Label:** Rebamipide

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Instillation,6 times/day for 4 weeks

**Intervention Names:**

- Drug: Hyalein Mini Ophthalmic solution

**Label:** Hyaluronate

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Rebamipide

**Description:** OPC-12759 Ophthalmic suspension 2%

**Name:** OPC-12759 Ophthalmic suspension

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Hyaluronate

**Description:** Hyalein Mini Ophthalmic solution 0.1%

**Name:** Hyalein Mini Ophthalmic solution

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups

**Measure:** Change in Fluorescein Corneal Staining (FCS) Score From Baseline

**Time Frame:** Baseline, Weeks4

**Description:** LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.

**Measure:** Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline

**Time Frame:** Baseline, Weeks4

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Out patient
2. Subjective complaint of dry eye that has been present for minimum 20 months
3. Ocular discomfort severity is moderate to severe
4. Corneal - conjunctival damage is moderate to severe
5. Unanesthetized Schirmer's test score of 5mm/5minutes or less
6. Best corrected visual acuity of 0.2 or better in both eyes

Exclusion Criteria:

1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
2. Ocular hypertension patient or glaucoma patient with ophthalmic solution
3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
4. Anticipated use of contact lens during the study
5. Patient with punctal plug
6. Any history of ocular surgery within 12 months
7. Female patients who are pregnant,possibly pregnant or breast feeding
8. Known hypersensitivity to any component of the study drug or procedural medications
9. Receipt of any investigational product within 4 months.

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kagoshima

**Country:** Japan

**Facility:** Kyushu region

**Location 2:**

**City:** Matsuyama

**Country:** Japan

**Facility:** Chushikoku region

**Location 3:**

**City:** Nagoya

**Country:** Japan

**Facility:** Tokai region

**Location 4:**

**City:** Osaka

**Country:** Japan

**Facility:** Kansai region

**Location 5:**

**City:** Tokyo

**Country:** Japan

**Facility:** Kanto region

#### Overall Officials

**Official 1:**

**Affiliation:** OPCJ-DDO

**Name:** Eiji Murakami

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007766

- Term: Lacrimal Apparatus Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000007637

- Term: Keratoconjunctivitis

- ID: D000003231

- Term: Conjunctivitis

- ID: D000003229

- Term: Conjunctival Diseases

- ID: D000007634

- Term: Keratitis

- ID: D000003316

- Term: Corneal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18040

- Name: Dry Eye Syndromes

- Relevance: HIGH

- As Found: Dry Eye Syndrome

- ID: M10664

- Name: Keratoconjunctivitis Sicca

- Relevance: HIGH

- As Found: Dry Eye

- ID: M10663

- Name: Keratoconjunctivitis

- Relevance: LOW

- As Found: Unknown

- ID: M10786

- Name: Lacrimal Apparatus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6455

- Name: Conjunctivitis

- Relevance: LOW

- As Found: Unknown

- ID: M6453

- Name: Conjunctival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10660

- Name: Keratitis

- Relevance: LOW

- As Found: Unknown

- ID: M6539

- Name: Corneal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015352

- Term: Dry Eye Syndromes

- ID: D000007638

- Term: Keratoconjunctivitis Sicca

### Intervention Browse Module - Ancestors

- ID: D000019999

- Term: Pharmaceutical Solutions

- ID: D000000897

- Term: Anti-Ulcer Agents

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M12814

- Name: Ophthalmic Solutions

- Relevance: HIGH

- As Found: Start

- ID: M246061

- Name: Rebamipide

- Relevance: HIGH

- As Found: Information and Communication

- ID: M4188

- Name: Antacids

- Relevance: LOW

- As Found: Unknown

- ID: M4219

- Name: Anti-Ulcer Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000052785

- Term: Rebamipide

- ID: D000009883

- Term: Ophthalmic Solutions

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Rebamipide

**Description:** Instillation,4 times/day for 4 weeks

OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%

**ID:** EG000

**Other Num Affected:** 27

**Other Num at Risk:** 93

**Serious Number At Risk:** 93

**Title:** Rebamipide

**Group ID:** EG001

**Title:** Hyaluronate

**Description:** Instillation,6 times/day for 4 weeks

Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%

**ID:** EG001

**Other Num Affected:** 19

**Other Num at Risk:** 95

**Serious Number At Risk:** 95

**Title:** Hyaluronate

**Frequency Threshold:** 1.0

#### Other Events

**Term:** Blepharitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Chalazion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Conjunctival haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Conjunctivitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Erythema of eyelid

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Eye discharge

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Eye irritation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Eye pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Eyelid oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Ocular hyperaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Vision blurred

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Visual impairment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Conjunctival hyperaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Eye pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Ocular discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Abdominal discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Gastritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Chest discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Thirst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Hepatic function abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Hordeolum

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (12.1)

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (12.1)

**Term:** Onychomycosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (12.1)

**Term:** Sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (12.1)

**Term:** Foreign body in eye

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (12.1)

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (12.1)

**Term:** Blood bilirubin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (12.1)

**Term:** Blood potassium increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (12.1)

**Term:** Blood urea increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (12.1)

**Term:** Blood urine present

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (12.1)

**Term:** White blood cell count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (12.1)

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (12.1)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Dysgeusia (bitter taste)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (12.1)

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (12.1)

**Term:** Dry mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (12.1)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 93

**Group ID:** BG001

**Value:** 95

**Group ID:** BG002

**Value:** 188

**Units:** Participants

### Group

**ID:** BG000

**Title:** Rebamipide

**Description:** Instillation,4 times/day for 4 weeks

OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%

### Group

**ID:** BG001

**Title:** Hyaluronate

**Description:** Instillation,6 times/day for 4 weeks

Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 55

#### Measurement

**Group ID:** BG001

**Value:** 59

#### Measurement

**Group ID:** BG002

**Value:** 114

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 38

#### Measurement

**Group ID:** BG001

**Value:** 36

#### Measurement

**Group ID:** BG002

**Value:** 74

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 17.7

**Value:** 58.0

#### Measurement

**Group ID:** BG001

**Spread:** 16.9

**Value:** 55.2

#### Measurement

**Group ID:** BG002

**Spread:** 17.4

**Value:** 56.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 83

#### Measurement

**Group ID:** BG001

**Value:** 80

#### Measurement

**Group ID:** BG002

**Value:** 163

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 25

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 93

#### Measurement

**Group ID:** BG001

**Value:** 95

#### Measurement

**Group ID:** BG002

**Value:** 188

**Class Title:** Japan

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Organization:** Otsuka Pharmaceutical Co., Ltd.
**Phone:** -81-6-6943-7722
**Title:** Mr. Kyoji Imaoka
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -1.47
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.24
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_DEVIATION
**Dispersion Value:** 2.1
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Non-inferiority for change from baseline in the FCS score was determined by comparing the non-inferiority margin (0.4) with the upper limit of the confidence interval of the difference between the 2 treatment groups.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** <0.05
**P-Value Comment:** An analysis of change from baseline of FCS was performed using t-test. The level of singnificanse was 5 % (2-sided).
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.9
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** True
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.05
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -2.1
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.3
- **Upper Limit:** 
- **Value:** -3.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.2
- **Upper Limit:** 
- **Value:** -2.9
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.2
- **Upper Limit:** 
- **Value:** -4.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.5
- **Upper Limit:** 
- **Value:** -2.4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks4
**Title:** Change in Fluorescein Corneal Staining (FCS) Score From Baseline
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Instillation,4 times/day for 4 weeks

OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%
**ID:** OG000
**Title:** Rebamipide
##### Group
**Description:** Instillation,6 times/day for 4 weeks

Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%
**ID:** OG001
**Title:** Hyaluronate
#### Outcome Measure 2
**Description:** LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks4
**Title:** Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Instillation,4 times/day for 4 weeks

OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%
**ID:** OG000
**Title:** Rebamipide
##### Group
**Description:** Instillation,6 times/day for 4 weeks

Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%
**ID:** OG001
**Title:** Hyaluronate
### Participant Flow Module
#### Group
**Description:** Instillation,4 times/day for 4 weeks

OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%
**ID:** FG000
**Title:** Rebamipide
#### Group
**Description:** Instillation,6 times/day for 4 weeks

Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%
**ID:** FG001
**Title:** Hyaluronate
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 93
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 95
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 91
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 91
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 4
**Has Results:** True