A Comparison of the Effect of Dorzolamide and Timolol on... | NCT00991822

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

NCT00991822

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Oct 8, 2009Estimated

Enrollment

160Actual

Phase

Phase 2Phase 3

Conditions

Glaucoma, Open-Angle

Interventions

Dorzolamide 2%
Timolol 0.5%

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1999

Primary Completion Date

Dec 2001Actual

Completion Date

Dec 2003Actual

First Submitted Date

Oct 7, 2009

First Submission Date that Met QC Criteria

Oct 7, 2009

First Posted Date

Oct 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2009

Last Update Posted Date

Oct 8, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Patients with open angle glaucoma	Drug: Dorzolamide 2%
2	Active Comparator	Patients with open angle glaucoma	Drug: Timolol 0.5%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dorzolamide 2%	Drug		1
Timolol 0.5%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans G Eichler, MD, Prof.	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Pharmacology, Medical University of Vienna		Vienna	State of Vienna	1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19850848	Derived	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.

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases