NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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.

Outcome(s)

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

Contact

public contact
Name
Address Japan
Telephone
E-mail ctrdinfo@kowa.co.jp
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
Telephone
E-mail
Affiliation The University of Tokyo, Graduate School of Medicine Department of Ophthalmology