Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues

Allergan

Status and phase: Completed; Phase 4

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Bimatoprost 0.03%; Drug: latanoprost 0.005% eye drops; Drug: travoprost 0.004%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00539526

MA-LUM-07-003

Details and patient eligibility

About

This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension

Exclusion criteria

• Known contraindication to latanoprost, bimatoprost or travoprost
• Uncontrolled systemic disease
• Active ocular disease other than glaucoma or ocular hypertension
• Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 3 patient groups

1

Experimental group

Description:

bimatoprost 0.03%

Treatment:

Drug: Bimatoprost 0.03%

2

Active Comparator group

Description:

travoprost 0.004%

Treatment:

Drug: travoprost 0.004%

3

Active Comparator group

Description:

latanoprost 0.005%

Treatment:

Drug: latanoprost 0.005% eye drops