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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


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


Minimum age: 29 Years. Maximum age: 80 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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