Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

Study Overview
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Brief Summary
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The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.

Conditions
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Ocular Hypertension, Glaucoma

Intervention / Treatment
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* Drug: AGN-210669 ophthalmic solution, 0.075%
* Drug: AGN-210669 ophthalmic solution, 0.05%
* Drug: AGN-210669 ophthalmic solution, 0.025%
* Drug: bimatoprost ophthalmic solution 0.03%
* Drug: AGN-210669 vehicle ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ocular hypertension or primary open-angle glaucoma Females of non-childbearing potential Subject requires IOP-lowering therapy in both eyes IOP ≥ 22 mm Hg and ≤ 34 mm Hg Has a visual acuity score of 20/100 or better in each eye Exclusion Criteria: Uncontrolled systemic disease Active ocular disease Alteration of existing chronic systemic medications Known allergy or sensitivity to the study medications Ophthalmic corticosteroids Visual field loss which in the opinion of the investigator is functionally significant History of ocular laser, intraocular surgery, or refractive surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-210669 ophthalmic solution, 0.075%<br>AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. | Drug: AGN-210669 ophthalmic solution, 0.075%<br>* AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.<br>|
| Experimental: AGN-210669 ophthalmic solution, 0.05%<br>AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. | Drug: AGN-210669 ophthalmic solution, 0.05%<br>* AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.<br>|
| Experimental: AGN-210669 ophthalmic solution, 0.025%<br>AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. | Drug: AGN-210669 ophthalmic solution, 0.025%<br>* AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.<br>|
| Active Comparator: bimatoprost ophthalmic solution 0.03%<br>Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. | Drug: bimatoprost ophthalmic solution 0.03%<br>* Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.<br>* Other names: Lumigan®;|
| Placebo Comparator: AGN-210669 vehicle ophthalmic solution<br>AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks. | Drug: AGN-210669 vehicle ophthalmic solution<br>* AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.<br>|

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 14 Hour 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP | IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day. | Baseline, Day 14 |