Conditions: Keratoconjunctivitis Sicca
Keywords: KCS dry eye cyclosporine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 745
Healthy volunteers: no

Brief summary:
This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.

Detailed description:

Arms:
arm 1: 0.09% cyclosporine nanomicellar ophthalmic solution arm 2: vehicle of OTX-101

Interventions: intervention 1: cyclosporine intervention 2: vehicle of OTX-101
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: