- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00928590
Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension
July 16, 2014 updated by: Alcon Research
A Twelve-Month Open-Label Safety Study of Polyquaternium-Preserved DuoTrav APS Dosed Once Daily in Patients With Open-Angle Glaucoma or Ocular Hypertension
The purpose of this study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
155
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:
- Willing and able to sign an informed consent document.
- Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator.
- Stable treatment of an IOP-lowering medication.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Pregnant, breastfeeding, or not using adequate birth control.
- Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters.
- Other protocol-defined exclusion criteria may apply.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DuoTrav APS
Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events (AEs)
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Theresa Landry, Ph.D, Alcon Research
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
July 1, 2009
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
June 24, 2009
First Submitted That Met QC Criteria
June 25, 2009
First Posted (Estimate)
June 26, 2009
Study Record Updates
Last Update Posted (Estimate)
July 18, 2014
Last Update Submitted That Met QC Criteria
July 16, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Luteolytic Agents
- Timolol
- Travoprost
- Cloprostenol
Other Study ID Numbers
- C-09-032
- EudraCT Number 2009-013178-42
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.
Clinical Trials on Ocular Hypertension
-
Western Galilee Hospital-NahariyaUnknown
-
Laboratoires TheaCompletedOcular Hypertension GlaucomaBulgaria
-
West Virginia UniversityUniversity of PittsburghRecruitingGlaucoma and Ocular HypertensionUnited States, United Kingdom, Canada
-
Santen Inc.Completed
-
Santen Inc.Completed
-
Maastricht University Medical CenterCompletedCorticosteroid Induced Ocular Hypertension/GlaucomaNetherlands
-
Santen Inc.CompletedA Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHTGlaucoma and Ocular HypertensionUnited States
-
University Hospital, GenevaTerminatedGlaucoma and Ocular HypertensionSwitzerland
-
Bausch & Lomb IncorporatedCompletedGlaucoma | Open Angle or Ocular HypertensionUnited States
-
Nicox Ophthalmics, Inc.CompletedGlaucoma, Open-Angle | Hypertension, OcularUnited States
Clinical Trials on Travoprost/Timolol Maleate Fixed Combination solution
-
University of Campinas, BrazilCompletedUveitis, Anterior | Cystoid Macular EdemaBrazil
-
Alcon ResearchCompleted
-
Alcon ResearchCompletedGlaucomaUnited States
-
Alcon ResearchTerminated
-
AllerganCompletedOcular Hypertension | Open-Angle GlaucomaCanada
-
Afyon Kocatepe University HospitalCompleted
-
Alcon ResearchCompletedOcular Hypertension | Open-angle GlaucomaUnited States
-
Bp Consulting, IncAllerganCompletedOcular Hypertension | Open-Angle GlaucomaCanada
-
Pharmaceutical Research NetworkCompleted
-
Aristotle University Of ThessalonikiAlcon ResearchCompleted