Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Open-Angle Glaucoma Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1099
Healthy volunteers: no

Brief 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.

Detailed 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).

Arms:
arm 1: Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months arm 2: Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months

Interventions: intervention 1: Travoprost ophthalmic solution, 0.003% intervention 2: Travoprost ophthalmic solution, 0.004%
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: