Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues

Phase 4

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: latanoprost 0.005% eye drops; Drug: Bimatoprost 0.03%; Drug: travoprost 0.004%

• Registration Number: NCT00539526
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-03
• Study First Posted: 2007-10-04
• Primary Completion: 2008-07
• Study Completion: 2008-09
• Results First Submitted: 2011-09-22
• Results First Submitted QC: 2011-09-22
• Results First Posted: 2011-10-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	latanoprost 0.005% eye drops	latanoprost 0.005%
1	Bimatoprost 0.03%	bimatoprost 0.03%
2	travoprost 0.004%	travoprost 0.004%

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3	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 Outcome Measures

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