Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues

Phase 4CompletedNCT00539526

Allergan106 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

106

Conditions

Open Angle Glaucoma Ocular Hypertension

Interventions

Bimatoprost 0.03%DRUG

bimatoprost 0.03%, 1 drop nightly for 3 months

travoprost 0.004%DRUG

travoprost 0.004% eye drops, 1 drop nightly for 3 months

latanoprost 0.005% eye dropsDRUG

latanoprost 0.005%, 1 drop nightly for 3 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

San Diego, California, United States

Outcomes

Primary Outcomes

Change From Baseline in Mean Conjunctival Hyperemia Scores at 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.

Time frame: Baseline, Month 3

Secondary Outcomes

Change From Baseline in Corneal Staining With Fluorescein at Month 3

Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement.

Time frame: Baseline, Month 3

Change From Baseline in Tear Break-Up Time (TBUT) at Month 3

Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.

Time frame: Baseline, Month 3

Data from ClinicalTrials.gov

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