Phase 3 Completed N=864 Randomized Triple-blind Treatment

Travoprost 3-Month Safety and Efficacy Study

Open-angle glaucoma · Hypertension

Source: ClinicalTrials.gov NCT01453855 ↗

Enrolled (actual)

864

Serious AEs

1.4%

Results posted

Oct 2013

Primary outcomePrimary: Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) — 19.4; 19.5; 18.6; 18.6 millimeters mercury (mmHg)

Summary

The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	19.4; 19.5; 18.6; 18.6; 18.0; 18.3	—

Eligibility Criteria

Inclusion Criteria

Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
Qualifying intraocular pressure at both eligibility visits.
Understand and sign an informed consent form.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
Severe central visual field loss in either eye.
Chronic, recurrent or severe inflammatory eye disease.
Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
Any abnormality preventing reliable applanation tonometry.
Hypersensitivity to prostaglandin analogs or to any component of the study medications.
Therapy with another investigational agent within 30 days prior to the Screening Visit.
Other protocol-defined exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01453855). 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.