To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.

Official Title
-----------------
A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

Conditions
-----------------
Keratoconjunctivitis Sicca

Intervention / Treatment
-----------------
* Drug: R348 Ophthalmic Solution, 0.2%
* Drug: R348 Ophthalmic Solution, 0.5%
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A history of dry eye (based on the date of initial dry eye symptoms) Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms Corneal fluorescein staining score of at least 2 in the inferior region Exclusion Criteria: History of, or a concurrent clinically significant illness, medical condition (other than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Use of ophthalmic cyclosporine within 45 days of Visit 1. Use of any topical ophthalmic steroid within 2 weeks of Visit 1. Have worn contact lenses or anticipate using contact lenses during the study. Have a condition or be in a situation that the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study. Have a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: R348 Ophthalmic Solution, 0.2%<br>R348 Ophthalmic Solution, 0.2% | Drug: R348 Ophthalmic Solution, 0.2%<br>* R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.<br>* Other names: R932348;|
| Active Comparator: R348 Ophthalmic Solution, 0.5%<br>R348 Ophthalmic Solution, 0.5% | Drug: R348 Ophthalmic Solution, 0.5%<br>* R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.<br>* Other names: R932348;|
| Placebo Comparator: Placebo<br>Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks. | Drug: Placebo<br>* Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Corneal Fluorescein Staining of the Inferior Cornea Region. | Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea. | Baseline to Week 12 |