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

Phase 2

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: AGN-210669; Drug: bimatoprost vehicle; Drug: bimatoprost

• Registration Number: NCT01291108
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-04
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-08
• Study Start: 2011-04
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Disposition First Submitted: 2012-10-17
• Disposition First Submitted QC: 2012-10-17
• Disposition First Posted: 2012-10-23
• Results First Submitted: 2013-08-13
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-04
• Last Update Submitted: 2013-11-04
• Results First Posted: 2013-11-06
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGN-210669	AGN-210669	AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
AGN-210669 + bimatoprost	AGN-210669	AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
AGN-210669 + bimatoprost vehicle	AGN-210669	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.
AGN-210669 + bimatoprost vehicle	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.
bimatoprost + bimatoprost vehicle	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.
bimatoprost + AGN-210669	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.
AGN-210669 + bimatoprost	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.
bimatoprost	bimatoprost	bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
bimatoprost + bimatoprost vehicle	bimatoprost	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.
bimatoprost + AGN-210669	bimatoprost	bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Average Eye IOP	Baseline, Day 57	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Worse Eye IOP	Baseline, Day 57	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.