Phase 4
N=106
Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
Open Angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00539526 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcome: Primary: Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3 — 0.74; 0.86; 0.74; 0.05 Scores on Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bimatoprost 0.03% (Drug); travoprost 0.004% (Drug); latanoprost 0.005% eye drops (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3 |
0.74; 0.86; 0.74; 0.05; 0.07; 0.06 | — |
| SECONDARY Change From Baseline in Corneal Staining With Fluorescein at Month 3 |
0.59; 0.48; 0.70; 0.15; -0.07; -0.18 | — |
| SECONDARY Change From Baseline in Tear Break-Up Time (TBUT) at Month 3 |
9.1; 7.9; 8.6; 0.5; 1.7; 0.4 | — |
Summary
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00539526). 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.