- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00508469
Adherence Assessment With Travalert Dosing Aid
June 8, 2012 updated by: Alcon Research
Adherence of Patients Using Travalert® for Instillation of a Fixed Combination of Travoprost 0.004%/Timolol 0.5% Compared to a Concomitant Regimen of Travoprost 0.004% and Timolol 0.5%
The purpose of the study is to compare adherence in patients on a fixed combination of travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004% and timolol 0.5% using the Travalert® device.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zaragoza, Spain, 50009
- Zaragoza
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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:
- Diagnosis of open-angle glaucoma or ocular hypertension;
- Inadequate control with beta-blocker or prostaglandin monotherapy and starting therapy with travoprost 0.004% and timolol 0.05%;
- Intraocular pressure (IOP) at the screening visit in at least one eye ≥ 19 mmHg but not exceeding 36 mmHg in either eye;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Females of childbearing potential currently pregnant, breastfeeding, or not taking control measures to prevent pregnancy;
- Not currently receiving treatment for lowering IOP with beta-blockers or prostaglandin analogs;
- Currently on therapy or was in therapy with another investigational agent within 30 days prior to the baseline visit;
- History of chronic or recurrent severe inflammatory eye disease, or history of ocular trauma within the past six (6) months, or history of ocular infection or ocular inflammation within the past three (3) months in either eye;
- History of clinically significant or progressive retinal disease or history of any other severe ocular pathology in either eye that would preclude the administration of a topical prostaglandin analogue;
- History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, to topical or systemic beta-blockers, or to any components of the study medication;
- Intraocular surgery within the past six (6) months or ocular laser surgery within the past three (3) months as determined by patient history and/or examination in either eye;
- Any abnormality preventing reliable applanation tonometry of either eye;
- Best-corrected visual acuity worse than 20/30 Snellen in either eye;
- Use of any additional topical or systemic ocular hyposensitive medication during the study;
- 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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Travalert with travoprost/timolol fixed combination
One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
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One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
Other Names:
Approved device used with study medication to record time of instillation and quantify dosing
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Experimental: Travalert with travoprost and timolol
One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
|
Approved device used with study medication to record time of instillation and quantify dosing
One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence
Time Frame: 6 months
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Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dr Francisco M. Honrubia, Independent
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
October 1, 2007
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
July 26, 2007
First Submitted That Met QC Criteria
July 27, 2007
First Posted (Estimate)
July 30, 2007
Study Record Updates
Last Update Posted (Estimate)
July 12, 2012
Last Update Submitted That Met QC Criteria
June 8, 2012
Last Verified
June 1, 2012
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
- Pharmaceutical Solutions
- Timolol
- Ophthalmic Solutions
- Travoprost
Other Study ID Numbers
- EMD-06-03
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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