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

NCT ID: NCT01452009

Last Updated: 2012-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open Angle Glaucoma Ocular Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Travoprost Ophthalmic Solution, 0.004% (New Formulation)

Group Type EXPERIMENTAL

Travoprost Ophthalmic Solution, 0.004% (New Formulation)

Intervention Type DRUG

Travoprost Ophthalmic Solution, 0.004% given one drop once daily

TRAVATAN®

TRAVATAN® administered one drop once daily

Group Type ACTIVE_COMPARATOR

TRAVATAN®

Intervention Type DRUG

TRAVATAN® administered one drop once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Travoprost Ophthalmic Solution, 0.004% (New Formulation)

Travoprost Ophthalmic Solution, 0.004% given one drop once daily

Intervention Type DRUG

TRAVATAN®

TRAVATAN® administered one drop once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C-10-151

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Divided Dose of TRAVATAN®
NCT01298687 COMPLETED PHASE2
Travoprost Five Day Posology Study
NCT01114893 COMPLETED PHASE2