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

Allergan

Status and phase: Completed; Phase 2

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: placebo; Drug: bimatoprost eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT00538304

192024-035

Details and patient eligibility

About

A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic glaucoma or ocular hypertension
• IOP controlled on Xalatan

Exclusion criteria

• Uncontrolled medical conditions
• Known hypersensitivity to study medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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222 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

bimatoprost eye drops

Treatment:

Drug: bimatoprost eye drops

2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo