Late Phase 2 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 evaluate the dose-response of OPC-12759 suspension in dry eye patients

Official Title
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Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: placebo
* Drug: 1% OPC-12759 ophthalmic suspension
* Drug: 2% OPC-12759 ophthalmic suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. | Drug: placebo<br>* comparison of different dosages of drug<br>|
| Experimental: 1% OPC-12759 ophthalmic suspension<br>1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. | Drug: 1% OPC-12759 ophthalmic suspension<br>* comparison of different dosages of drug<br>|
| Experimental: 2% OPC-12759 ophthalmic suspension<br>2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. | Drug: 2% OPC-12759 ophthalmic suspension<br>* comparison of different dosages of drug<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 to Last Observation Carried Forward (LOCF) | 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.The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero. | Baseline, 4weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF) | LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctival sac and the conjunctina was divided into 6 ractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-18). 0 is better. The CFB to each study time point was compared between the active-drug groups and the placebo group, and LOCF endpoint scores were used to compare the active-drug groups and the placebo group. In each treatment group, baseline scores and those obtained at each study time point were compared. | Baseline, 4weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Syndromes, OPC-12759