Chronic Graft-versus-host Disease Clinical Trial
— DROPS-2Official 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 for the Treatment of Keratoconjunctivitis Sicca in Patients With Chronic Ocular Graft Versus Host Disease
Verified date | July 2016 |
Source | Rigel Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
- 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.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts |
United States | U. Miami - Bascom Palmer Eye Institute | Plantation | Florida |
Lead Sponsor | Collaborator |
---|---|
Rigel Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change of total Corneal fluorescein staining score | Baseline to 12 weeks | No |
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