Confirmatory Study of OPC-12759 Ophthalmic Solution

Study Overview
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Brief Summary
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The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.

Official Title
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Confirmatory Study of OPC-12759 Ophthalmic Solution in Patients With Dry Eye

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: OPC-12759
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out patient Subjective complaint of dry eye that has been present for minimum 20 months Ocular discomfort severity is moderate to severe Corneal - conjunctival damage is moderate to severe Unanesthetized Schirmer's test score of 5mm/5minutes or less Best corrected visual acuity of 0.2 or better in both eyes Exclusion Criteria: Presence of anterior segment disease or disorder other than that associated with dry eye Ocular hypertension patient or glaucoma patient with ophthalmic solution Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study Anticipated use of contact lens during the study Patient with punctal plug Any history of ocular surgery within 12 months Female patients who are pregnant,possibly pregnant or breast feeding Known hypersensitivity to any component of the study drug or procedural medications Receipt of any investigational product within 4 months.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC-12759 ophthalmic solution<br>OPC-12759 ophthalmic solution | Drug: OPC-12759<br>* Instillation, 4 times/day for 4 weeks<br>* Other names: rebamipide;|
| Placebo Comparator: Placebo<br>OPC-12759 ophthalmic solution 0% | Drug: Placebo<br> <br> |
| Active Comparator: OPC-12759 ophthalmic suspension<br>OPC-12759 ophthalmic suspension | Drug: OPC-12759<br>* Instillation, 4 times/day for 4 weeks<br>* Other names: rebamipide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fluorescein Corneal Staining (FCS) Score From Baseline | 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. Changes of the FCS score from baseline to the last dose (last observation carried forward [LOCF]) were compared between 2% OPC-12759 ophthalmic solution and placebo by the t-test. | Baseline, Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline | 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 score from 0 to 3, and the total score was calculated (0-18). 0 is better. The scores and change from baseline at each examination (including LOCF) were compared between 2% OPC-12759 ophthalmic solution and placebo ophthalmic solution. | Baseline, Week 4 |