Status:
WITHDRAWN
The Effects of Cosopt® Vs Xalacom® on Ocular Hemodynamics and Intraocular Pressure (IOP) in Primary Open-angle Glaucoma (POAG)
Lead Sponsor:
Meir Medical Center
Conditions:
Open-Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Both Cosopt® and Xalatan® plus Timoptic® will significantly lower IOP, however only Cosopt® will demonstrate positive hemodynamic effects. The clinical significance of this will be investigated by exa...
Detailed Description
Background and Rationale Apoptosis of retinal ganglion cell has been considered as the most plausible pathogenic mechanism of glaucoma. Apoptosis can be caused by neurotrophic factor withdrawal or gl...
Eligibility Criteria
Inclusion
- 18 years of age or greater.
- Patient signed an informed consent agreement.
- Corrected visual acuity of 6/12 or better:
- Characteristic glaucomatous visual-field loss and optic nerve head damage in one or both eyes.
- Either IOP measurements ≥21 mmHg in the 3 months prior to study entry or IOP ≥ 21 mmHg at the end of the washout period
- Patient on ≥1 IOP reducing agents. -
Exclusion
- Past history of ocular diseases (other than OAG / Cataract / Refractive error).
- Past history of orbital/ocular surgery or trauma.
- Receiving ≥ 3 IOP reducing agents.
- Receiving agents known to produce significant cardiovascular, respiratory, renal or hepatic side effects.
- Personal history of respiratory disease such as asthma, emphysema or other chronic obstructive pulmonary disease.
- Personal history of congestive heart failure.
- Personal history of bradycardia or 2nd and 3rd degree AV block.
- Known allergy to sulfa.
- Women who are pregnant or nursing.
- Women who of child bearing age who are planning to become pregnant within one month after study completion.
- Receiving Levitra, Viagra, Cialis or other erectile dysfunction drugs.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00815373
Start Date
December 1 2008
End Date
June 1 2012
Last Update
March 16 2012
Active Locations (1)
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1
Meir Medical Center
Kfar Saba, Israel