24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost
Information source: Aristotle University Of Thessaloniki
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Intervention: Travoprost/timolol fixed combination, travoprost (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Aristotle University Of Thessaloniki Official(s) and/or principal investigator(s): Anastasios GP Konstas, MD, PhD, Principal Investigator, Affiliation: Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Mean 24-hour IOP
Secondary outcome: Mean reduction from baselineMean fluctuation of 24-hour IOP Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.
Eligibility
Minimum age: 29 Years.
Maximum age: 81 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Glaucoma Unit, 1st University Department of Ophthalmology, Thessaloniki 546 36, Greece
Additional Information
Starting date: March 2007
Last updated: May 9, 2014
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