Safety and Efficacy Study of Bimatoprost in Ethnically Japanese Patients With Open-Angle Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 2

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Bimatoprost Vehicle Ophthalmic Solution; Drug: Bimatoprost 0.03% Ophthalmic Solution; Drug: Bimatoprost 0.01% Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651859

192024-024

Details and patient eligibility

About

This study evaluates the safety and efficacy of once-daily bimatoprost 0.03% and 0.01% ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic solution for 2 weeks in ethnically Japanese patients with open-angle glaucoma or ocular hypertension

Enrollment: 111 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ethnically Japanese patients with glaucoma or ocular hypertension in each eye who require IOP-lowering therapy in both eyes

Exclusion criteria

• Uncontrolled systemic disease
• Use of bimatoprost or an ocular prostaglandin (eg, latanoprost, travoprost) within 6 weeks prior to baseline (Day 0)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Bimatoprost 0.01% Ophthalmic Solution

Treatment:

Drug: Bimatoprost 0.01% Ophthalmic Solution

2

Experimental group

Description:

Bimatoprost 0.03% Ophthalmic Solution

Treatment:

Drug: Bimatoprost 0.03% Ophthalmic Solution

3

Placebo Comparator group

Description:

Bimatoprost Vehicle Ophthalmic Solution

Treatment:

Drug: Bimatoprost Vehicle Ophthalmic Solution