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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: AGN-210669 ophthalmic solution, 0.075%; Drug: AGN-210669 ophthalmic solution, 0.05%; Drug: AGN-210669 ophthalmic solution, 0.025%; Drug: bimatoprost ophthalmic solution 0.03%; Drug: AGN-210669 vehicle ophthalmic solution

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.
Active Comparator: bimatoprost ophthalmic solution 0.03%; Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.	Drug: bimatoprost ophthalmic solution 0.03%; Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.; Other Names: Lumigan®
Placebo Comparator: AGN-210669 vehicle ophthalmic solution; AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.	Drug: AGN-210669 vehicle ophthalmic solution; AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Average Eye Intraocular Pressure (IOP)	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).	Baseline, Day 14 Hour 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP	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.	Baseline, Day 14

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: December 16, 2008
• First Submitted That Met QC Criteria: December 16, 2008
• First Posted (Estimate): December 17, 2008

Study Record Updates

• Last Update Posted (Estimate): October 18, 2013
• Last Update Submitted That Met QC Criteria: August 13, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Bimatoprost
• Other Study ID Numbers: 210669-003