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24-hr Intraocular Pressure Control With Dorzolamide/Timolol vs the Brimonidine/Timolol Fixed Combination

This study has been completed.
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki Identifier:
First received: September 3, 2009
Last updated: May 9, 2014
Last verified: May 2014
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.

Condition Intervention Phase
Glaucoma Drug: treatment with dorzolamide/timolol Drug: treatment with brimonidine/timolol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AGP Konstas, Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Assess fluctuation of 24-hour pressure [ Time Frame: 3 months ]

Enrollment: 64
Study Start Date: January 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Drug: Dorzolamide/Timolol Drug: treatment with dorzolamide/timolol
24-hour IOP control with the two fixed combinations
Active Comparator: Treatment with Brimonidine/Timolol Drug: treatment with brimonidine/timolol
24-hour pressure control with brimonidine/timolol


Ages Eligible for Study:   29 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00972257

Glaucoma Unit, 1st University Dept of Ophthalmology
Thessaloniki, Greece, 546 36
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Principal Investigator: Anastasios Konstas, MD, phD Head of Glaucoma Unit
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki Identifier: NCT00972257     History of Changes
Other Study ID Numbers: A5132
Study First Received: September 3, 2009
Last Updated: May 9, 2014

Keywords provided by AGP Konstas, Aristotle University Of Thessaloniki:
24-hour IOP control
primary open-angle glaucoma

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Brimonidine Tartrate
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors processed this record on September 21, 2017