- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01452009
Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%
February 9, 2012 updated by: Alcon Research
Three Month Safety and Efficacy Study of TRAVATAN® vs Travoprost Ophthalmic Solution, 0.004%
A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients 18 years of age or older
- Either gender
- Any race/ethnicity
- Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension
Exclusion Criteria:
- Patients with any form of glaucoma other than open-angle glaucoma.
- Patients with a central cornea thickness greater than 620 μm
- Patients with Shaffer angle Grade < 2
- Patients with a cup/disc ratio greater than 0.80
- Patients with severe central visual field loss
- Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent)
- Chronic, recurrent or severe inflammatory eye disease
- Clinically significant or progressive retinal disease
- Other ocular pathology
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Travoprost Ophthalmic Solution, 0.004% (New Formulation)
|
Travoprost Ophthalmic Solution, 0.004% given one drop once daily
|
Active Comparator: TRAVATAN®
TRAVATAN® administered one drop once daily
|
TRAVATAN® administered one drop once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy: mean IOP Efficacy as measured by mean IOP
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
October 12, 2011
First Submitted That Met QC Criteria
October 13, 2011
First Posted (Estimate)
October 14, 2011
Study Record Updates
Last Update Posted (Estimate)
February 10, 2012
Last Update Submitted That Met QC Criteria
February 9, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-10-151
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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