Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)

Study Overview
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Brief Summary
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To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to subjects evaluated by objective and subjective measures. To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.

Official Title
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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 for the Treatment of Keratoconjunctivitis Sicca in Patients With Chronic Ocular Graft Versus Host Disease

Conditions
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Chronic Graft-versus-host Disease

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received an Allogeneic hematologic stem cell transplantation at least 3 months prior. Subjects with post Allogeneic hematologic stem cell transplantation onset or worsening of dry eye symptoms for at least 1 month prior. Use of over-the-counter and/or prescription eye drops for dry eye symptoms within 1 month. Corneal fluorescein staining score of ≥ 2 in 1 region and ≥ 1 in at least 1 other region. Total lissamine green conjunctival staining score (according to a modified National Eye Institute grading system) of ≥ 2. Exclusion Criteria: Clinically unstable Graft versus Host Disease (requiring a change in immunosuppressive regimen), medical condition, or laboratory abnormality Used topical ophthalmic cyclosporine within 45 days. Used any topical ophthalmic steroid within 2 weeks. Used autologous serum eye drops within 2 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Active Comparator: R348 Ophthalmic Solution, 0.2%<br>R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day | Drug: R348 Ophthalmic Solution, 0.2%<br>* R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day<br>* Other names: R932348;|
| Active Comparator: R348 Ophthalmic Solution, 0.5%<br>R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day | Drug: R348 Ophthalmic Solution, 0.5%<br>* R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day<br>* Other names: R932348;|
| Placebo Comparator: Placebo<br>Placebo Ophthalmic Solution 2 drops per eye twice a day | Other: Placebo Ophthalmic Solution<br>* Placebo Ophthalmic Solution 2 drops per eye twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks. | Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea. | Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Graft versus Host Disease, Keratoconjunctivitis Sicca