Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)
Phase 2
Completed
- Conditions
- Chronic Graft-versus-host Disease
- Interventions
- Drug: R348 Ophthalmic Solution, 0.2%Drug: R348 Ophthalmic Solution, 0.5%Other: Placebo Ophthalmic Solution
- Registration Number
- NCT02040623
- Lead Sponsor
- Rigel Pharmaceuticals
- Brief Summary
* 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day R348 Ophthalmic Solution, 0.5% R348 Ophthalmic Solution, 0.5% R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day Placebo Placebo Ophthalmic Solution Placebo Ophthalmic Solution 2 drops per eye twice a day
- Primary Outcome Measures
Name Time Method Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks. Baseline to 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
U. Miami - Bascom Palmer Eye Institute
🇺🇸Plantation, Florida, United States
Massachusetts Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States
U. Miami - Bascom Palmer Eye Institute🇺🇸Plantation, Florida, United States