24-hr Intraocular Pressure Control With Dorzolamide/Timolol vs the Brimonidine/Timolol Fixed Combination
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: treatment with dorzolamide/timolol (Drug); treatment with brimonidine/timolol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Aristotle University Of Thessaloniki Official(s) and/or principal investigator(s):
Anastasios Konstas, MD, phD, Principal Investigator, Affiliation: Head of Glaucoma Unit
Summary
The proposed study will compare for the first time the quality of 24-hour IOP control with
Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination
(DTFC) after a run-in period of 2 months with timolol. This crossover comparison may
determine the real efficacy of the two fixed combinations and the design of the proposed
study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less
than might be anticipated.
Clinical Details
Official title: Quality of 24-hour Intraocular Pressure Control Obtained With Dorzolamide/Timolol Fixed Combination (DTFC) Compared With the Brimonidine/Timolol Fixed Combination (BTFC) 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: To compare the quality of 24-hour IOP control after 2 months of chronic therapy with the Dorzolamide/Timolol fixed combination versus the Brimonidine/Timolol fixed combination in primary open-angle glaucoma.
Secondary outcome: Assess fluctuation of 24-hour pressure
Eligibility
Minimum age: 29 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Consecutive, newly diagnosed or previously untreated POAG patients
- Patients with typical glaucomatous disc, or visual field damage
- Patient must have IOP (at 10: 00 ± 1 hour)greater than 25 mm Hg
Exclusion Criteria:
- Uncontrolled glaucoma
- Distance best corrected Snellen visual acuity worse than 1/10
- Contraindications to brimonidine or dorzolamide and β-blockers
- History of lack of response (<10% morning IOP reduction) to any medication
- Patient can not understand the instructions and adhere to medications
- Patient is a female of childbearing potential or lactating mother
- Prior surgery, past use of steroids (within 2 months)
- Severe dry eyes and use of contact lenses
- History of non-adherence
- Patients with closed angles
Locations and Contacts
Glaucoma Unit, 1st University Dept of Ophthalmology, Thessaloniki 546 36, Greece
Additional Information
Starting date: January 2009
Last updated: May 9, 2014
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