A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)

Allergan

Status and phase: Completed; Phase 4

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Drug: Bimatoprost 0.01%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01594970

APMA-001211

Details and patient eligibility

About

This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).

Enrollment: 800 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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800 participants in 3 patient groups

Bimatoprost 0.01% (Naive Monotherapy)

Experimental group

Description:

1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.

Treatment:

Drug: Bimatoprost 0.01%

Bimatoprost 0.01% (Switched Monotherapy)

Experimental group

Description:

1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.

Treatment:

Drug: Bimatoprost 0.01%

Bimatoprost 0.01% (with Adjunctive Therapy)

Experimental group

Description:

1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.

Treatment:

Drug: Bimatoprost 0.01%