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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01452009

Enrollment

Registered

2011-10-14

Start date

2011-11-30

Completion date

2011-12-31

Last updated

2012-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open Angle Glaucoma

Keywords

open angle glaucoma, ocular hypertension

Brief summary

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

Interventions

DRUGTravoprost Ophthalmic Solution, 0.004% (New Formulation)

Travoprost Ophthalmic Solution, 0.004% given one drop once daily

DRUGTRAVATAN®

TRAVATAN® administered one drop once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Efficacy: mean IOP Efficacy as measured by mean IOP	3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026