Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

Conditions
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Ocular Hypertension, Primary Open-Angle Glaucoma

Intervention / Treatment
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* Drug: AGN-210961 Formulation 1
* Drug: AGN-210961 Formulation 2
* Drug: AGN-210961 Formulation 3
* Drug: AGN-210961 Formulation 4
* Drug: AGN-210961 Formulation 5
* Drug: AGN-210961 Formulation 6
* Drug: AGN-210961 Formulation 7
* 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 Exclusion Criteria: Any active ocular disease Anticipated wearing of contact lenses during study Anticipated use of artificial tears during study Contraindication to pupil dilatation

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: Part 1, AGN-210961 Formulation 1<br>AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. | Drug: AGN-210961 Formulation 1<br>* AGN-210961 Formulation 1 in one eye once daily for 7 days.<br>|
| Experimental: Part 1, AGN-210961 Formulation 2<br>AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. | Drug: AGN-210961 Formulation 2<br>* AGN-210961 Formulation 2 in one eye once daily for 7 days.<br>|
| Experimental: Part 1, AGN-210961 Formulation 3<br>AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. | Drug: AGN-210961 Formulation 3<br>* AGN-210961 Formulation 3 in one eye once daily for 7 days.<br>|
| Experimental: Part 1, AGN-210961 Formulation 4<br>AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. | Drug: AGN-210961 Formulation 4<br>* AGN-210961 Formulation 4 in one eye once daily for 7 days.<br>|
| Experimental: Part 1, AGN-210961 Formulation 5<br>AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. | Drug: AGN-210961 Formulation 5<br>* AGN-210961 Formulation 5 in one eye once daily for 7 days.<br>|
| Experimental: Part 1, AGN-210961 Formulation 6<br>AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. | Drug: AGN-210961 Formulation 6<br>* AGN-210961 Formulation 6 in one eye once daily for 7 days.<br>|
| Experimental: Part 2, AGN-210961 Formulation 7<br>AGN-210961 Formulation 7 in both eyes once daily for 4 weeks. | Drug: AGN-210961 Formulation 7<br>* AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.<br>|
| Active Comparator: Part 2, bimatoprost ophthalmic solution 0.03%<br>bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks. | Drug: bimatoprost ophthalmic solution 0.03%<br>* bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.<br>* Other names: LUMIGAN®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups. | Baseline, Day 7 | 
| Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12. | Baseline, Day 29 |