Confirmatory Study of OPC-12759 Ophthalmic Suspension

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

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: OPC-12759 Ophthalmic suspension
* Drug: Hyalein Mini Ophthalmic solution


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 keratoconjunctivitis sicca 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rebamipide<br>Instillation,4 times/day for 4 weeks | Drug: OPC-12759 Ophthalmic suspension<br>* OPC-12759 Ophthalmic suspension 2%<br>|
| Active Comparator: Hyaluronate<br>Instillation,6 times/day for 4 weeks | Drug: Hyalein Mini Ophthalmic solution<br>* Hyalein Mini Ophthalmic solution 0.1%<br>|

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. 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 | Baseline, Weeks4 | 
| 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 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. | Baseline, Weeks4 |