Conditions: Dry Eye Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 834
Healthy volunteers: no

Brief summary:
The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).

Detailed description:
This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.

Arms:
arm 1: Cyclosporine A solution in vehicle arm 2: Vehicle only

Interventions: intervention 1: CyclASol topical ocular, eye drops intervention 2: Vehicle topical ocular, eye drops
Intervention descriptions: intervention 1: Cyclosporine A solution in vehicle intervention 2: Vehicle

Protocol document:
Prot_SAP_000.pdf: