Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Bimatoprost 0.03% Ophthalmic Solution; Drug: Bimatoprost 0.03% Formulation B Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01099774

192024-048

Details and patient eligibility

About

This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension

Enrollment: 597 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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597 participants in 2 patient groups

Bimatoprost 0.03% Formulation B Ophthalmic Solution

Experimental group

Description:

Bimatoprost 0.03% Formulation B Ophthalmic Solution

Treatment:

Drug: Bimatoprost 0.03% Formulation B Ophthalmic Solution

Bimatoprost 0.03% Ophthalmic Solution

Active Comparator group

Description:

Bimatoprost 0.03% Ophthalmic Solution

Treatment:

Drug: Bimatoprost 0.03% Ophthalmic Solution