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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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Medical University of Vienna

Status and phase

Completed
Phase 3
Phase 2

Conditions

Glaucoma, Open-Angle

Treatments

Drug: Dorzolamide 2%
Drug: Timolol 0.5%

Study type

Interventional

Funder types

Other

Identifiers

NCT00991822
OPHT-200198

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

19+ years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

160 participants in 2 patient groups

1
Active Comparator group
Description:
Patients with open angle glaucoma
Treatment:
Drug: Dorzolamide 2%
2
Active Comparator group
Description:
Patients with open angle glaucoma
Treatment:
Drug: Timolol 0.5%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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