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

Glaucoma, Open-Angle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991822
• Other study ID #: OPHT-200198
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 7, 2009
• Last updated: October 7, 2009
• Start date: May 1999
• Est. completion date: December 2003

Study information

• Verified date: October 2009
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2003
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Drug:
• Dorzolamide 2%

• Timolol 0.5%

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No