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

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
treatment with dorzolamide/timolol
treatment with brimonidine/timolol
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring 24-hour IOP control, primary open-angle glaucoma, brimonidine/timolol, dorzolamide/timolol

Eligibility Criteria

29 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Glaucoma Unit, 1st University Dept of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Drug: Dorzolamide/Timolol

Treatment with Brimonidine/Timolol

Arm Description

Outcomes

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.

Secondary Outcome Measures

Assess fluctuation of 24-hour pressure

Full Information

First Posted
September 3, 2009
Last Updated
May 9, 2014
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT00972257
Brief Title
24-hr Intraocular Pressure Control With Dorzolamide/Timolol vs the Brimonidine/Timolol Fixed Combination
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
24-hour IOP control, primary open-angle glaucoma, brimonidine/timolol, dorzolamide/timolol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug: Dorzolamide/Timolol
Arm Type
Active Comparator
Arm Title
Treatment with Brimonidine/Timolol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
treatment with dorzolamide/timolol
Intervention Description
24-hour IOP control with the two fixed combinations
Intervention Type
Drug
Intervention Name(s)
treatment with brimonidine/timolol
Intervention Description
24-hour pressure control with brimonidine/timolol
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Assess fluctuation of 24-hour pressure
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasios Konstas, MD, phD
Organizational Affiliation
Head of Glaucoma Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glaucoma Unit, 1st University Dept of Ophthalmology
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
21960068
Citation
Konstas AG, Quaranta L, Yan DB, Mikropoulos DG, Riva I, Gill NK, Barton K, Haidich AB. Twenty-four hour efficacy with the dorzolamide/timolol-fixed combination compared with the brimonidine/timolol-fixed combination in primary open-angle glaucoma. Eye (Lond). 2012 Jan;26(1):80-7. doi: 10.1038/eye.2011.239. Epub 2011 Sep 30.
Results Reference
derived

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

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