Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 2

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Bimatoprost 0.03% ophthalmic solution; Drug: Bimatoprost 0.015% formulation 2 ophthalmic solution; Drug: Bimatoprost 0.015% formulation 1 ophthalmic solution; Drug: Bimatoprost 0.01% ophthalmic solution; Drug: Bimatoprost 0.02% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652496

192024-030

Details and patient eligibility

About

This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient

Enrollment: 249 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ocular hypertension or glaucoma in both eyes
• Require IOP-lowering therapy in each eye

Exclusion criteria

• Uncontrolled systemic disease
• Known allergy or hypersensitivity to bimatoprost

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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249 participants in 5 patient groups

1

Experimental group

Description:

Bimatoprost 0.01% ophthalmic solution

Treatment:

Drug: Bimatoprost 0.01% ophthalmic solution

2

Experimental group

Description:

Bimatoprost 0.015% formulation 1 ophthalmic solution

Treatment:

Drug: Bimatoprost 0.015% formulation 1 ophthalmic solution

3

Experimental group

Description:

Bimatoprost 0.015% formulation 2 ophthalmic solution

Treatment:

Drug: Bimatoprost 0.015% formulation 2 ophthalmic solution

4

Experimental group

Description:

Bimatoprost 0.02% ophthalmic solution

Treatment:

Drug: Bimatoprost 0.02% ophthalmic solution

5

Active Comparator group

Description:

Bimatoprost 0.03% ophthalmic solution

Treatment:

Drug: Bimatoprost 0.03% ophthalmic solution