NIPH Clinical Trials Search

UMIN ID: C000000422

Registered date:25/05/2006

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.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedNormal Tension Glaucoma
Date of first enrollment2002/04/01
Target sample size150
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)1 drop of 0.25% nipradilol ophthalmic solution is used in each eye two times a day for 3 years. 1 drop of 0.5% timolol ophthalmic solution is used in each eye two times a day for 3 years.


Primary OutcomeO'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-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

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum60years-old
GenderMale and Female
Include criteria
Exclude criteriaPatients 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

Related Information


public contact
Address Japan
Affiliation KOWA company, ltd. Clinical Research Management Dept.Pharmaceutical Development Dept.
scientific contact
Name Makoto Araie
Address 3-1, 7-chome, Hongo, Bunkyo-ku, Tokyo 133-8655, JAPAN Japan
Affiliation The University of Tokyo, Graduate School of Medicine Department of Ophthalmology