Conditions: Dry Eye Syndromes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 236
Healthy volunteers: no

Brief summary:
This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.

Detailed description:

Arms:
arm 1: 1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. arm 2: 1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. arm 3: 1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. arm 4: 1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days.

Interventions: intervention 1: AGN-223575 ophthalmic solution intervention 2: AGN-223575 vehicle ophthalmic solution
Intervention descriptions: intervention 1: AGN-223575 ophthalmic solution once or twice daily intervention 2: Vehicle to AGN22375 ophthalmic solution once or twice daily.

Protocol document: