Conditions: Keratoconjunctivitis Sicca
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 204
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: R348 Ophthalmic Solution, 0.2% arm 2: R348 Ophthalmic Solution, 0.5% arm 3: Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.

Interventions: intervention 1: R348 Ophthalmic Solution, 0.2% intervention 2: R348 Ophthalmic Solution, 0.5% intervention 3: Placebo
Intervention descriptions: intervention 1: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks. intervention 2: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks. intervention 3: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.

Protocol document: