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Randomized double blind comparative study of nipradilol, an alfa-1,beta-blocker with a nitric oxide donative action, and timolol, a non-selective beta-blocker, on the visual field in Japanese patients with normal-tension glaucoma.

Phase 4
Conditions
ormal Tension Glaucoma
Registration Number
JPRN-C000000422
Lead Sponsor
KOWA company, ltd.
Brief Summary

The effect of topical nipradilol and timolol on progression of visual field damage and IOP was found to be equivalent in Japanese NTG patients whose untreated IOP was 14mmHg.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
150
Inclusion Criteria

Not provided

Exclusion Criteria

Patients with -Cataract which affects the visual field or corrected vision of <0.8 -Refraction of <-0.8D or >5.0D -A history of invasive eye surgery -Complication with serious retinal disease that affects the visual field -Complications which require treatment using the following prohibited drugs: i.e., drugs that influence intraocular pressure or blood flow, and drugs that have neuroprotective action -Complication with diabetes mellitus -Pulse rate of 50/min or less -Routine systolic blood pressure of 110 mmHg or below -Patients who are pregnant, nursing or are suspected of being pregnant

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
O&#39;Brien score of each patient derived from the regression coefficient against time of mean sensitivity (MD value) by cluster measured using the Humphrey Field Analyzer C30-2
Secondary Outcome Measures
NameTimeMethod
-Regression coefficient of MD value against time -Regression coefficient of MD value against time by cluster -Regression coefficient of corrected pattern standard deviation (CPSD) value against time -Time to event of progression of visual field defect -Intraocular pressure -Time to occurrence of optic disc hemorrhage -Time to occurrence of optic disc progression
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