Dose-response Study of OPC-12759 Ophthalmic Suspension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.

Official Title
-----------------
Dose-response Study of OPC-12759 Ophthalmic Suspension

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: 0.5% OPC-12759
* Drug: 1% OPC-12759
* Drug: 2% OPC-12759
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient. Subjective complaint of dry eye that has been present for minimum 20 months. Primary ocular discomfort severity is moderate to severe. Corneal - conjunctival damage is moderate to severe. Unanesthetized Schirmer's test score of 7mm/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. Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study. Anticipated use of contact lens during the study. 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
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5% OPC-12759<br>0.5% OPC-12759 (rebamipide) ophthalmic suspension | Drug: 0.5% OPC-12759<br> <br> |
| Experimental: 1% OPC-12759<br>1% OPC-12759 (rebamipide) ophthalmic suspension | Drug: 1% OPC-12759<br> <br> |
| Experimental: 2% OPC-12759<br>2% OPC-12759 (rebamipide) ophthalmic suspension | Drug: 2% OPC-12759<br> <br> |
| Placebo Comparator: placebo<br>placebo of OPC-12759 (rebamipide) ophthalmic suspension | Drug: placebo<br> <br> |

What is the study measuring?
-----------------
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, 12 weeks | 
| Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF) | POD indicates the ocular symptom most bothersome to the patient. POD selected by each patient from among the following ocular symptoms; Foreign body sensation, Dryness, Photophobia, Eye pain and Blurred vision. POD was scored from 0 through 4; a score of 0 indicated no symptoms and a score of 4 indicated very severe symptoms. 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, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OPC-12759, Dry eye syndromes