NCT01110499

Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

Conditions

• Ocular Hypertension
• Primary Open-Angle Glaucoma

Interventions

Type	Name	Description
DRUG	AGN-210961 Formulation 1	AGN-210961 Formulation 1 in one eye once daily for 7 days.
DRUG	AGN-210961 Formulation 2	AGN-210961 Formulation 2 in one eye once daily for 7 days.
DRUG	AGN-210961 Formulation 3	AGN-210961 Formulation 3 in one eye once daily for 7 days.
DRUG	AGN-210961 Formulation 4	AGN-210961 Formulation 4 in one eye once daily for 7 days.
DRUG	AGN-210961 Formulation 5	AGN-210961 Formulation 5 in one eye once daily for 7 days.
DRUG	AGN-210961 Formulation 6	AGN-210961 Formulation 6 in one eye once daily for 7 days.
DRUG	AGN-210961 Formulation 7	AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
DRUG	bimatoprost ophthalmic solution 0.03%	bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2010-04-26
• Last updated: 2014-08-05
• Results posted: 2014-08-05

Locations

1 site across 1 country: United States