A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Bimatoprost 0.03%; Drug: Bimatoprost 0.01%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01830140

192024-081

Details and patient eligibility

About

This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).

Enrollment: 466 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of glaucoma or ocular hypertension

Exclusion criteria

• Active ocular disease other than glaucoma or ocular hypertension
• Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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466 participants in 2 patient groups

Bimatoprost 0.01%

Experimental group

Description:

Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.

Treatment:

Drug: Bimatoprost 0.01%

Bimatoprost 0.03%

Active Comparator group

Description:

Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.

Treatment:

Drug: Bimatoprost 0.03%