Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension

Phase 4

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: travoprost ophthalmic solution 0.004%; Drug: latanoprost ophthalmic solution 0.005%; Drug: bimatoprost ophthalmic solution 0.01%

• Registration Number: NCT01253902
• Lead Sponsor: Allergan

Brief Summary

This study evaluated the ocular surface tolerability of the prostaglandin analogues bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004% (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients previously treated with Xalatan® who have open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-10
• Results First Submitted: 2012-10-08
• Results First Submitted QC: 2012-10-08
• Last Update Submitted: 2012-10-08
• Results First Posted: 2012-11-07
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication
• Best corrected visual acuity score of 20/100 or better in both eyes
• Females on birth control pills must be on same type of pill and dose for at least 3 month

Exclusion Criteria

• Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months
• History of or active ocular infection/inflammation (eg, uveitis)
• Punctal plug use
• Required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable)
• Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months
• History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s)
• Planned contact lens wear during study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
travoprost ophthalmic solution 0.004%	travoprost ophthalmic solution 0.004%	One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
latanoprost ophthalmic solution 0.005%	latanoprost ophthalmic solution 0.005%	One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
bimatoprost ophthalmic solution 0.01%	bimatoprost ophthalmic solution 0.01%	One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Mean Conjunctival Hyperemia at Week 12	Week 12	Conjunctival hyperemia was analyzed using the average of the scores of both eyes. 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 on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness).

Secondary Outcome Measures

Name	Time	Method
Mean Corneal Staining With Fluorescein at Week 12	Week 12	Corneal staining was analyzed using the average of the scores of both eyes. 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=None (no puncta), 0.5=Trace (1-5 puncta), 1=Mild (6-20 puncta), 2=Moderate (\>20 puncta) and 3=Severe (too many puncta to count).
Mean Tear Break Up Time (TBUT) at Week 12	Week 12	Tear Break Up Time was analyzed using the average of the readings of both eyes. 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.