Travoprost 3-Month Safety and Efficacy Study

Alcon

Status and phase: Completed; Phase 3

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost ophthalmic solution, 0.004%; Drug: Travoprost ophthalmic solution, 0.003%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01453855

2011-004587-29 (EudraCT Number)

C-11-034

Details and patient eligibility

About

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.

Full description

This study consisted of six visits conducted during two sequential phases. The Screening/Eligibility phase included one screening visit and two eligibility visits. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1) at the second eligibility visit. The Treatment phase consisted of three on-therapy visits (Week 2, Week 6, and Month 3).

Enrollment: 1,099 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1,099 participants in 2 patient groups

Travoprost 0.003%

Experimental group

Description:

Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months

Treatment:

Drug: Travoprost ophthalmic solution, 0.003%

TRAVATAN

Active Comparator group

Description:

Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months

Treatment:

Drug: Travoprost ophthalmic solution, 0.004%