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

Phase 1

Completed

• Conditions: Ocular Hypertension; Glaucoma
• Interventions: Drug: AGN-210669 ophthalmic solution, 0.025%; Drug: AGN-210669 ophthalmic solution, 0.05%; Drug: bimatoprost ophthalmic solution 0.03%; Drug: AGN-210669 ophthalmic solution, 0.075%; Drug: AGN-210669 vehicle ophthalmic solution

• Registration Number: NCT00809848
• Lead Sponsor: Allergan

Brief Summary

The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Study Start: 2009-02
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Disposition First Submitted: 2011-03-31
• Disposition First Submitted QC: 2011-03-31
• Disposition First Posted: 2011-04-07
• 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: 172

Inclusion Criteria

• Ocular hypertension or primary open-angle glaucoma
• Females of non-childbearing potential
• Subject requires IOP-lowering therapy in both eyes
• IOP ≥ 22 mm Hg and ≤ 34 mm Hg
• Has a visual acuity score of 20/100 or better in each eye

Exclusion Criteria

• Uncontrolled systemic disease
• Active ocular disease
• Alteration of existing chronic systemic medications
• Known allergy or sensitivity to the study medications
• Ophthalmic corticosteroids
• Visual field loss which in the opinion of the investigator is functionally significant
• History of ocular laser, intraocular surgery, or refractive surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGN-210669 ophthalmic solution, 0.025%	AGN-210669 ophthalmic solution, 0.025%	AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
AGN-210669 ophthalmic solution, 0.05%	AGN-210669 ophthalmic solution, 0.05%	AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
bimatoprost ophthalmic solution 0.03%	bimatoprost ophthalmic solution 0.03%	Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
AGN-210669 ophthalmic solution, 0.075%	AGN-210669 ophthalmic solution, 0.075%	AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
AGN-210669 vehicle ophthalmic solution	AGN-210669 vehicle ophthalmic solution	AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Average Eye Intraocular Pressure (IOP)	Baseline, Day 14 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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP	Baseline, Day 14	IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.