Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution

Phase 2

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: AGN-210669 ophthalmic solution, 0.075%; Drug: bimatoprost ophthalmic solution 0.03%; Drug: AGN-210669 ophthalmic solution, 0.1%; Drug: AGN-210669 ophthalmic solution, 0.05%

• Registration Number: NCT01001195
• Lead Sponsor: Allergan

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®).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Study Start: 2009-11
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Disposition First Submitted: 2011-05-03
• Disposition First Submitted QC: 2011-05-03
• Disposition First Posted: 2011-05-05
• Status Verified: 2013-08
• Results First Submitted: 2013-08-13
• Results First Submitted QC: 2013-08-13
• Last Update Submitted: 2013-08-13
• Results First Posted: 2013-10-18
• Last Update Posted: 2013-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGN-210669 ophthalmic solution, 0.075%	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.
bimatoprost ophthalmic solution 0.03%	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.
AGN-210669 ophthalmic solution, 0.1%	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.
AGN-210669 ophthalmic solution, 0.05%	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Average Eye Intraocular Pressure (IOP)	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).