Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

Study Overview
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Brief Summary
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This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)
* Drug: timolol ophthalmic solution 0.5%
* Drug: AGN-207281 vehicle ophthalmic solution (Placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ocular hypertension or primary open-angle glaucoma in each eye Requires IOP-lowering therapy in both eyes Visual acuity score of 20/100 or better in each eye Exclusion Criteria: Experienced significant weight change (over 10 pounds) within 60 days History of alcohol or drug addiction History of migraines or frequent headaches Anticipated wearing of contact lenses during the study Required chronic use of ocular medications during study Eye surgery within 6 months Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months Use of oral, intramuscular, intravenous corticosteroids within 21 days Use of ophthalmic corticosteroids within 2 months

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 |
| --- | --- |
| Other: AGN-207281 ophthalmic solution<br>AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14 | Drug: AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)<br>* One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days.<br>|
| Active Comparator: Timolol ophthalmic solution 0.5%<br>timolol ophthalmic solution 0.5% | Drug: timolol ophthalmic solution 0.5%<br>* One drop of timolol ophthalmic solution 0.5% instilled to both eyes, in the morning for 14 days, and in the evening for 13 days<br>|
| Placebo Comparator: Placebo<br>AGN-207281 vehicle ophthalmic solution (Placebo) | Drug: AGN-207281 vehicle ophthalmic solution (Placebo)<br>* One drop of AGN-207281 vehicle ophthalmic solution instilled to both eyes, in the morning for 14 days and in the evening for 13 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement). | Baseline, Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Concentration of AGN-207281 in Plasma at Day 7 | Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281. | Day 7 | 
| Mean Concentration of AGN-207281 in Plasma at Day 14 | Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281. | Day 14 |