Phase 4
N=164
Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
Glaucoma, Open-Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01253902 ↗Enrolled (actual)
164
Serious AEs
3.1%
Results posted
Nov 2012
Primary outcome: Primary: Mean Conjunctival Hyperemia at Week 12 — 0.42; 0.46; 0.44 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- bimatoprost ophthalmic solution 0.01% (Drug); travoprost ophthalmic solution 0.004% (Drug); latanoprost ophthalmic solution 0.005% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Conjunctival Hyperemia at Week 12 |
0.42; 0.46; 0.44 | — |
| SECONDARY Mean Corneal Staining With Fluorescein at Week 12 |
0.31; 0.32; 0.22 | — |
| SECONDARY Mean Tear Break Up Time (TBUT) at Week 12 |
9.7; 9.7; 9.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01253902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.