NCT00991822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 1999

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
Last Updated

October 8, 2009

Status Verified

October 1, 2009

Enrollment Period

2.6 years

First QC Date

October 7, 2009

Last Update Submit

October 7, 2009

Conditions

Glaucoma, Open-Angle

Keywords

open angle glaucomatimololdorzolamide

Outcome Measures

Primary Outcomes (2)

  • Percent change over baseline after 3 months of treatment of optic disk blood flow measured with the Heidelberg Retina Flowmeter

    5 minutes measurement of optic disk blood flow on 3 study days

  • Percent change over baseline after 3 months of treatment of fundus pulsation amplitude (FPA) in the optic disk as assessed with laser interferometry

    5 minutes measurement of FPA on 3 study days

Study Arms (2)

1

ACTIVE COMPARATOR

Patients with open angle glaucoma

Drug: Dorzolamide 2%

2

ACTIVE COMPARATOR

Patients with open angle glaucoma

Drug: Timolol 0.5%

Interventions

Dorzolamide 2%DRUG
1
Timolol 0.5%DRUG
2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 19850848DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Hans G Eichler, MD, Prof.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

May 1, 1999

Primary Completion

December 1, 2001

Study Completion

December 1, 2003

Last Updated

October 8, 2009

Record last verified: 2009-10

Locations

AU(1)