Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues

Allergan0 sites106 target enrollmentSeptember 2007

ConditionsOpen Angle Glaucoma Ocular Hypertension

InterventionsBimatoprost 0.03%travoprost 0.004%latanoprost 0.005% eye drops

DrugsBimatoprost 0.03%travoprost 0.004%latanoprost 0.005% eye drops

Overview

Phase: Phase 4
Intervention: Bimatoprost 0.03%
Conditions: Open Angle Glaucoma
Sponsor: Allergan
Enrollment: 106
Primary Endpoint: Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

September 2008

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

1

bimatoprost 0.03%

Intervention: Bimatoprost 0.03%

2

travoprost 0.004%

Intervention: travoprost 0.004%

3

latanoprost 0.005%

Intervention: latanoprost 0.005% eye drops

Outcomes

Primary Outcomes

Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3

Time Frame: Baseline, Month 3

Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.

Secondary Outcomes

Change From Baseline in Corneal Staining With Fluorescein at Month 3(Baseline, Month 3)
Change From Baseline in Tear Break-Up Time (TBUT) at Month 3(Baseline, Month 3)