Conditions: Chronic Graft-versus-host Disease
Keywords: Chronic Graft versus Host Disease Keratoconjunctivitis Sicca
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 35
Healthy volunteers: no

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:

Arms:
arm 1: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day arm 2: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day arm 3: Placebo Ophthalmic Solution 2 drops per eye twice a day

Interventions: intervention 1: R348 Ophthalmic Solution, 0.2% intervention 2: R348 Ophthalmic Solution, 0.5% intervention 3: Placebo Ophthalmic Solution
Intervention descriptions: intervention 1: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day intervention 2: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day intervention 3: Placebo Ophthalmic Solution 2 drops per eye twice a day

Protocol document: