Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Allergan

Status and phase

Completed

Phase 3

Conditions

Glaucoma

Ocular Hypertension

Treatments

Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution

Drug: bimatoprost/timolol fixed combination ophthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT01177098

192024-050

2010-021507-24 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.

Enrollment

561 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has ocular hypertension or glaucoma in both eyes
Requires IOP-lowering therapy in each eye

Exclusion criteria

Active or recurrent eye disease that would interfere with interpretation of study data in either eye
History of any eye surgery or laser in either eye within 6 months
Required chronic use of other eye medications during the study
Anticipated wearing of contact lenses during the study.
Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days