Phase 4
N=156
Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure
Open Angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02003391 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye — 16.6129; 21.2320 mmHg — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Beta-blocker monotherapy (Drug); Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye |
16.6129; 21.2320 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye |
-5.840; -1.069 | — |
| SECONDARY Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye |
-25.365; -4.716 | — |
Summary
The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with open-angle glaucoma or ocular hypertension.
Eligibility Criteria
Inclusion Criteria
- Have a clinical diagnosis of either open angle glaucoma or ocular hypertension.
- Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction.
- Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye.
- Must be able to understand and sign an Informed Consent form.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Use of medication excluded by the protocol.
- Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol.
- Ocular surgeries or procedures excluded by the protocol.
- Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
- Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator.
- Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02003391). 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.