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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00972257
First received: September 3, 2009
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess fluctuation of 24-hour pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   29 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972257

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

No publications provided by Aristotle University Of Thessaloniki

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00972257     History of Changes
Other Study ID Numbers: A5132
Study First Received: September 3, 2009
Last Updated: May 9, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:
24-hour IOP control
primary open-angle glaucoma
brimonidine/timolol
dorzolamide/timolol

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Timolol
Brimonidine
Dorzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014