Status:
COMPLETED
Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma
Lead Sponsor:
The Catholic University of Korea
Collaborating Sponsors:
Seoul St. Mary's Hospital
Conditions:
Normal Tension Glaucoma
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
To prove the non-inferiority of the fixed timolol-dorzolamide combination (Cosopt) compared to 0.005% latanoprost (Xalatan) in the aspects of intraocular pressure (IOP) and ocular perfusion pressure (...
Detailed Description
Cosopt (dorzolamide/timolol fixed combination) has well known effect for IOP reduction in POAG and OHT.3-5 However, there is no study about the effect and safety of Cosopt in NTG, Cosopt is not used t...
Eligibility Criteria
Inclusion
- The identification of NTG was based on reproducible glaucomatous visual field defects, corresponding to typical ONH changes.
- Unilateral or bilateral visual field loss (description as below) as determined by at least two consecutive automated static threshold perimetry tests.
- One eye is randomly selected in the cases where both eyes are treated.
- Inclusion criteria:
- age ranging from 45 to 75 years
- best-corrected visual acuity no worse than 20/30 Snellen equivalent
- optic nerve head cupping (i.e., a vertical cup-to-disc ratio of more than 0.6) and/or notching of neuroretinal rim, and/or retinal nerve fiber defects characteristic of glaucoma
- visual field loss (i.e., a localized defect with at least three adjacent nonedge points depressed \>5 dB from the normal value, and a nucleus of at least one point depressed 10 dB from the normal value)
- repeated measurements of untreated IOP, which documented values less than 22 mmHg
- central corneal thickness ranging from 540 to 560 microns
- open-angle confirmed by gonioscopy
- Exclusion criteria:
- active or chronic systemic diseases and/or concomitant assumption of any medication known to affect IOP, BP and/or HR
- corneal abnormalities preventing reliable applanation tonometry
- severe ocular trauma, ocular inflammation or infection, intraocular surgery or argon laser treatment or laser trabeculoplasty
- myopic or other fundus changes preventing reliable optic disc evaluation,
- visual field defects caused by nonglaucomatous disease
- history of allergy to the ingredients of Cosopt or Xalatan eye drops
Exclusion
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01175902
Start Date
March 1 2011
End Date
October 1 2014
Last Update
January 8 2015
Active Locations (1)
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1
Seoul St. Mary's hospital
Seoul, South Korea, 137-070