Phase 4
Completed N=111
Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT00763061 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcomePrimary: Mean Intraocular Pressure (IOP) at 9 AM — 16.3; 18.1 millimeters mercury (mmHg)
Summary
To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Intraocular Pressure (IOP) at 9 AM |
16.3; 18.1 | — |
| PRIMARY Week 12 - Mean IOP At 4 PM |
15.7; 17.9 | — |
| SECONDARY Mean IOP Change From Baseline at 9 AM |
-5.1; -4.4 | — |
| SECONDARY Mean IOP Change at 4 PM |
-5.3; -3.7 | — |
Eligibility Criteria
Inclusion Criteria
- ≥18 years;
- IOP=16-30mmHg
- OH or OAG with visual filed abnormality:
- ≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%,
- Glaucoma Hemifield Test outside normal limits,
- Corrected Pattern Standard Deviation with p <5%
Exclusion Criteria
- Previous damage of anterior chamber angle;
- ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;
- contact lens wearer;
- severe central field loss;
- uncontrolled cardiovascular, hepatic or renal disease;
- any medication within past 1 month.
Data sourced from ClinicalTrials.gov (NCT00763061). 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. Informational only — not medical advice.