Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution

Allergan

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Drug: AGN-210669 ophthalmic solution, 0.1%; Drug: AGN-210669 ophthalmic solution, 0.05%; Drug: AGN-210669 ophthalmic solution, 0.075%; Drug: bimatoprost ophthalmic solution 0.03%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001195

210669-010

Details and patient eligibility

About

This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ocular hypertension or primary open-angle glaucoma in each eye
• Patient requires IOP lowering medication in each eye

Exclusion criteria

• Ocular hyperemia or other ocular surface findings in either eye
• Active ocular disease
• Current or anticipated use of any topical ocular medication (including artificial tears) during the study
• Intraocular surgery within past six months or unilateral cataract surgery.
• Functionally significant visual field loss
• Anticipated wearing of contact lenses during study
• Use of other medications that affect IOP such as glaucoma treating medications, within 2 months of screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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165 participants in 4 patient groups

AGN-210669 ophthalmic solution, 0.1%

Experimental group

Description:

One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Treatment:

Drug: AGN-210669 ophthalmic solution, 0.1%

AGN-210669 ophthalmic solution, 0.075%

Experimental group

Description:

One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Treatment:

Drug: AGN-210669 ophthalmic solution, 0.075%

AGN-210669 ophthalmic solution, 0.05%

Experimental group

Description:

One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Treatment:

Drug: AGN-210669 ophthalmic solution, 0.05%

bimatoprost ophthalmic solution 0.03%

Active Comparator group

Description:

One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Treatment:

Drug: bimatoprost ophthalmic solution 0.03%