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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Intervention / Treatment: Drug: AGN-210669; Drug: bimatoprost; Drug: bimatoprost vehicle

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (Estimate): February 8, 2011

Study Record Updates

• Last Update Posted (Estimate): November 6, 2013
• Last Update Submitted That Met QC Criteria: November 4, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: 210669-013