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

Study Overview
=================
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.

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: bimatoprost ophthalmic solution 0.01%
* Drug: travoprost ophthalmic solution 0.004%
* Drug: latanoprost ophthalmic solution 0.005%


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bimatoprost ophthalmic solution 0.01%<br>One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks. | Drug: bimatoprost ophthalmic solution 0.01%<br>* One drop of bimatoprost ophthalmic solution 0.01% administered to affected eye(s), once daily in the evening for 12 weeks.<br>* Other names: Lumigan® 0.01%, Lumigan® RC;|
| Active Comparator: travoprost ophthalmic solution 0.004%<br>One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks. | Drug: travoprost ophthalmic solution 0.004%<br>* One drop of travoprost ophthalmic solution 0.004% administered to affected eye(s), once daily in the evening for 12 weeks.<br>* Other names: Travatan Z®;|
| Active Comparator: latanoprost ophthalmic solution 0.005%<br>One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks. | Drug: latanoprost ophthalmic solution 0.005%<br>* One drop of latanoprost ophthalmic solution 0.005% administered to affected eye(s), once daily in the evening for 12 weeks.<br>* Other names: Xalatan®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Conjunctival Hyperemia at 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). | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Corneal Staining With Fluorescein at 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). | Week 12 | 
| Mean Tear Break Up Time (TBUT) at 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. | Week 12 |