Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%

Alcon

Status and phase: Withdrawn; Phase 3

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost Ophthalmic Solution, 0.004% (New Formulation); Drug: TRAVATAN®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01452009

C-10-151

Details and patient eligibility

About

A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients 18 years of age or older
2. Either gender
3. Any race/ethnicity
4. Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension

Exclusion criteria

1. Patients with any form of glaucoma other than open-angle glaucoma.
2. Patients with a central cornea thickness greater than 620 μm
3. Patients with Shaffer angle Grade < 2
4. Patients with a cup/disc ratio greater than 0.80
5. Patients with severe central visual field loss
6. Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent)
7. Chronic, recurrent or severe inflammatory eye disease
8. Clinically significant or progressive retinal disease
9. Other ocular pathology

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Travoprost Ophthalmic Solution, 0.004% (New Formulation)

Experimental group

Treatment:

Drug: Travoprost Ophthalmic Solution, 0.004% (New Formulation)

TRAVATAN®

Active Comparator group

Description:

TRAVATAN® administered one drop once daily

Treatment:

Drug: TRAVATAN®