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A Comparison of the Effect of Dorzolamide and Timolol on Optic Disk Blood Flow in Patients With Open Angle Glaucoma

Primary Purpose

Glaucoma, Open-Angle

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Dorzolamide 2%
Timolol 0.5%
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glaucoma, Open-Angle focused on measuring open angle glaucoma, timolol, dorzolamide

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women older than 19 years
  • Primary open angle glaucoma or ocular hypertension with IOP higher than 22 mmHg in at least one eye
  • Washout period for previous antiglaucoma treatment: two weeks for adrenergic agonists, one week for parasympathomimetic agents

Exclusion Criteria:

  • Exfoliation glaucoma, pigmentary glaucoma
  • History of acute angle closure
  • Intraocular surgery or argon laser trabeculoplasty within the last 6 months
  • Ocular inflammation or infection within the last 3 months
  • Contact lenses
  • Patients with bradycardia (heart rate less than 50 beats/min)
  • Second or third degree heart block
  • Asthma
  • COPD
  • Congestive Heart Failure
  • Severe renal impairment (Creatinine clearance less than 1.8 l/h
  • History or hypersensitivity to one of the study drugs or drugs with similar chemical structure
  • History of non-IOP responder to beta-blockers or carbonic anhydrase inhibitors
  • Pregnancy

Sites / Locations

  • Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Patients with open angle glaucoma

Patients with open angle glaucoma

Outcomes

Primary Outcome Measures

Percent change over baseline after 3 months of treatment of optic disk blood flow measured with the Heidelberg Retina Flowmeter
Percent change over baseline after 3 months of treatment of fundus pulsation amplitude (FPA) in the optic disk as assessed with laser interferometry

Secondary Outcome Measures

Full Information

First Posted
October 7, 2009
Last Updated
October 7, 2009
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00991822
Brief Title
A Comparison of the Effect of Dorzolamide and Timolol on Optic Disk Blood Flow in Patients With Open Angle Glaucoma
Official Title
A Double-masked Comparison of the Effect of Dorzolamide and Timolol on Optic Disk Blood Flow in Patients With Open Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Glaucoma is one of the most common causes of blindness in the industrialized nations. For a long time glaucoma has been defined as a disease in which high intraocular pressure (IOP) leads to irreversible optic disk damage and concommitant visual field loss. However, recent investigations show that IOP is not necessarily an adequate measure of clinical severity or a predictor of clinical progression: about 20% of all eyes with high IOP do not develop visual field loss and some patients suffering from visual field loss due to optic disk damage have normal IOP. Hence, factors other than IOP are likely involved in the pathogenesis of glaucoma. The role of vascular factors in the pathogenesis of glaucoma has recently received much attention and optic nerve head hypoperfusion may play a critical role in the development of glaucoma. It may therefore be important for an optimal prevention of visual field defects in glaucoma that the topical antiglaucoma drugs used do not only reduce IOP but also stabilize or enhance the perfusion of the optic nerve head. Therefore, the aim of the present study is to compare the effect of a 3 months treatment with timolol or dorzolamide in patients with open angle glaucoma on optic disk blood flow.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
Keywords
open angle glaucoma, timolol, dorzolamide

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients with open angle glaucoma
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients with open angle glaucoma
Intervention Type
Drug
Intervention Name(s)
Dorzolamide 2%
Intervention Type
Drug
Intervention Name(s)
Timolol 0.5%
Primary Outcome Measure Information:
Title
Percent change over baseline after 3 months of treatment of optic disk blood flow measured with the Heidelberg Retina Flowmeter
Time Frame
5 minutes measurement of optic disk blood flow on 3 study days
Title
Percent change over baseline after 3 months of treatment of fundus pulsation amplitude (FPA) in the optic disk as assessed with laser interferometry
Time Frame
5 minutes measurement of FPA on 3 study days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women older than 19 years Primary open angle glaucoma or ocular hypertension with IOP higher than 22 mmHg in at least one eye Washout period for previous antiglaucoma treatment: two weeks for adrenergic agonists, one week for parasympathomimetic agents Exclusion Criteria: Exfoliation glaucoma, pigmentary glaucoma History of acute angle closure Intraocular surgery or argon laser trabeculoplasty within the last 6 months Ocular inflammation or infection within the last 3 months Contact lenses Patients with bradycardia (heart rate less than 50 beats/min) Second or third degree heart block Asthma COPD Congestive Heart Failure Severe renal impairment (Creatinine clearance less than 1.8 l/h History or hypersensitivity to one of the study drugs or drugs with similar chemical structure History of non-IOP responder to beta-blockers or carbonic anhydrase inhibitors Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans G Eichler, MD, Prof.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
19850848
Citation
Fuchsjager-Mayrl G, Georgopoulos M, Hommer A, Weigert G, Pemp B, Vass C, Garhofer G, Schmetterer L. Effect of dorzolamide and timolol on ocular pressure: blood flow relationship in patients with primary open-angle glaucoma and ocular hypertension. Invest Ophthalmol Vis Sci. 2010 Mar;51(3):1289-96. doi: 10.1167/iovs.09-3827. Epub 2009 Oct 22.
Results Reference
derived

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A Comparison of the Effect of Dorzolamide and Timolol on Optic Disk Blood Flow in Patients With Open Angle Glaucoma

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