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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-05-31

Study Completion Date

2003-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Patients with open angle glaucoma

Group Type ACTIVE_COMPARATOR

Dorzolamide 2%

Intervention Type DRUG

2

Patients with open angle glaucoma

Group Type ACTIVE_COMPARATOR

Timolol 0.5%

Intervention Type DRUG

Interventions

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Dorzolamide 2%

Intervention Type DRUG

Timolol 0.5%

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No