Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease

Allergan

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: AGN-223575 vehicle ophthalmic solution; Drug: AGN-223575 ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02435914

223575-002

Details and patient eligibility

About

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.

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signs and symptoms of dry eye disease
• Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.

Exclusion criteria

• History of glaucoma, or ocular hypertension
• Diagnosis of ocular infection
• Use of contact lenses in the past 14 days or expected use during the study
• Use of any topical ophthalmic medications in the past 30 days
• Use of corticosteroids in the past 30 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

236 participants in 4 patient groups, including a placebo group

AGN-223575 Dose A

Experimental group

Description:

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.

Treatment:

Drug: AGN-223575 ophthalmic solution

Drug: AGN-223575 vehicle ophthalmic solution

AGN-223575 Dose B

Experimental group

Description:

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.

Treatment:

Drug: AGN-223575 ophthalmic solution

Drug: AGN-223575 vehicle ophthalmic solution

AGN-223575 Dose C

Experimental group

Description:

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.

Treatment:

Drug: AGN-223575 ophthalmic solution

Drug: AGN-223575 vehicle ophthalmic solution

AGN-223575 Vehicle

Placebo Comparator group

Description:

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.

Treatment:

Drug: AGN-223575 vehicle ophthalmic solution