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

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: AGN-210669
* Drug: bimatoprost
* Drug: bimatoprost vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye Requires bilateral treatment with an IOP-lowering medication Best corrected visual acuity of 20/100 or better in each eye Exclusion Criteria: Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months Inability to fast for up to 10 hours Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy) Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months Current or anticipated use of artificial tears or any ocular medications aside from study medications during study Anticipated wearing of contact lenses during study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-210669<br>AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1. | Drug: AGN-210669<br>* AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.<br>|
| Experimental: AGN-210669 + bimatoprost<br>AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2. | Drug: AGN-210669<br>* AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.<br>Drug: bimatoprost<br>* bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.<br>* Other names: LUMIGAN®;|
| Experimental: AGN-210669 + bimatoprost vehicle<br>AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. | Drug: AGN-210669<br>* AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.<br>Drug: bimatoprost vehicle<br>* bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.<br>|
| Active Comparator: bimatoprost<br>bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1. | Drug: bimatoprost<br>* bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.<br>* Other names: LUMIGAN®;|
| Experimental: bimatoprost + AGN-210669<br>bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2. | Drug: AGN-210669<br>* AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.<br>Drug: bimatoprost<br>* bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.<br>* Other names: LUMIGAN®;|
| Other: bimatoprost + bimatoprost vehicle<br>bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. | Drug: bimatoprost<br>* bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.<br>* Other names: LUMIGAN®;Drug: bimatoprost vehicle<br>* bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average Eye IOP | IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are 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). Data are recorded at Hours 0, 4, 8, and 12. | Baseline, Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Worse Eye IOP | IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. 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). Data are recorded at Hours 0, 4, 8, and 12. | Baseline, Day 57 |