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

Study Overview
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Brief Summary
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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®).

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: AGN-210669 ophthalmic solution, 0.1%
* Drug: AGN-210669 ophthalmic solution, 0.075%
* Drug: AGN-210669 ophthalmic solution, 0.05%
* Drug: bimatoprost ophthalmic solution 0.03%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-210669 ophthalmic solution, 0.1%<br>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. | Drug: AGN-210669 ophthalmic solution, 0.1%<br>* 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.<br>|
| Experimental: AGN-210669 ophthalmic solution, 0.075%<br>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. | Drug: AGN-210669 ophthalmic solution, 0.075%<br>* 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.<br>|
| Experimental: AGN-210669 ophthalmic solution, 0.05%<br>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. | Drug: AGN-210669 ophthalmic solution, 0.05%<br>* 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.<br>|
| Active Comparator: bimatoprost ophthalmic solution 0.03%<br>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. | Drug: bimatoprost ophthalmic solution 0.03%<br>* 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.<br>* Other names: LUMIGAN®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average Eye Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). | Baseline, Day 29 Hour 0 |