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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00991822
Enrollment
160
Registered
2009-10-08
Start date
1999-05-31
Completion date
2003-12-31
Last updated
2009-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Open-Angle

Keywords

open angle glaucoma, timolol, dorzolamide

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.

Interventions

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percent change over baseline after 3 months of treatment of optic disk blood flow measured with the Heidelberg Retina Flowmeter5 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 interferometry5 minutes measurement of FPA on 3 study days

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026