Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution
Overview
- Phase
- Phase 2
- Intervention
- AGN-210669 ophthalmic solution, 0.1%
- Conditions
- Glaucoma, Open-Angle
- Sponsor
- Allergan
- Enrollment
- 165
- Primary Endpoint
- Change From Baseline in Average Eye Intraocular Pressure (IOP)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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®).
Investigators
Eligibility Criteria
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
Arms & Interventions
AGN-210669 ophthalmic solution, 0.1%
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.
Intervention: AGN-210669 ophthalmic solution, 0.1%
AGN-210669 ophthalmic solution, 0.075%
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.
Intervention: AGN-210669 ophthalmic solution, 0.075%
AGN-210669 ophthalmic solution, 0.05%
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.
Intervention: AGN-210669 ophthalmic solution, 0.05%
bimatoprost ophthalmic solution 0.03%
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.
Intervention: bimatoprost ophthalmic solution 0.03%
Outcomes
Primary Outcomes
Change From Baseline in Average Eye Intraocular Pressure (IOP)
Time Frame: Baseline, Day 29 Hour 0
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).