- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00444184
24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost
May 9, 2014 updated by: AGP Konstas, Aristotle University Of Thessaloniki
A Crossover, Double-Masked Comparison Investigating the 24-Hour Intraocular Pressure Control With the Travoprost/Timolol Fixed Combination Versus Travoprost, When Both Are Given in the Evening, in Subjects With Primary Open-Angle Glaucoma
This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening.
Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy.
The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe.
Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol.
This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
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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Thessaloniki, Greece, 546 36
- Glaucoma Unit, 1st University Department of Ophthalmology
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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
29 years to 81 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00).
- Patient has POAG and is older than 29 years
- The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00)
- Patient can be safely washed out without risk for significant deterioration
- Distance best corrected Snellen visual acuity better than 1/10
- Patient can understand the instructions and comply to medications
- Open normal appearing angles
Exclusion Criteria:
- Contraindications to prostaglandins or β-blockers
- History of lack of response (<10% reduction) to any medication
- Female of childbearing potential or lactating mother
- History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- Sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc
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: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Travoprost/Timolol therapy
24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops
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|
Active Comparator: Travoprost therapy
24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean 24-hour IOP
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean reduction from baseline
Time Frame: 3 months
|
3 months
|
Mean fluctuation of 24-hour IOP
Time Frame: 3 months
|
3 months
|
Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Anastasios GP Konstas, MD, PhD, Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology
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
March 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
March 5, 2007
First Submitted That Met QC Criteria
March 5, 2007
First Posted (Estimate)
March 7, 2007
Study Record Updates
Last Update Posted (Estimate)
May 12, 2014
Last Update Submitted That Met QC Criteria
May 9, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A3243
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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