Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

Allergan

Status: Completed

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution; Drug: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01068964

192024-052

Details and patient eligibility

About

This study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or ocular hypertension

Enrollment: 235 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes
• Eye pressure lowering topical medications are not working
• Visual acuity is at least 0.2 in each eye

Exclusion criteria

• Uncontrolled systemic disease
• Any other active eye disease other than glaucoma or ocular hypertension
• Significant visual field loss or evidence of progressive visual field loss within the last year
• Anticipated wearing of contact lenses during the study
• Required chronic use of other ocular medications during the study
• Eye surgery or laser treatment within 12 weeks prior to study enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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235 participants in 2 patient groups

0.03% Bimatoprost/0.5% Timolol in Same Bottle

Experimental group

Description:

Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution

Treatment:

Drug: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution

0.03% Bimatoprost and 0.5% Timolol in Separate Bottles

Active Comparator group

Description:

Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution

Treatment:

Drug: 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution