Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 164
- Primary Endpoint
- Mean Conjunctival Hyperemia at Week 12
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: bimatoprost ophthalmic solution 0.01% (Drug)
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.
Intervention: travoprost ophthalmic solution 0.004% (Drug)
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.
Intervention: latanoprost ophthalmic solution 0.005% (Drug)
Outcomes
Primary Outcomes
Mean Conjunctival Hyperemia at Week 12
Time Frame: 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 Outcomes
- Mean Corneal Staining With Fluorescein at Week 12(Week 12)
- Mean Tear Break Up Time (TBUT) at Week 12(Week 12)