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) studied | Normal Tension Glaucoma |
| Date of first enrollment | 2002/04/01 |
| Target sample size | 150 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| 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 Outcome | O'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 minimum | 20years-old |
|---|---|
| Age maximum | 60years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | KOWA company, ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | KOWA company, ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| 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 | |
| Affiliation | The University of Tokyo, Graduate School of Medicine Department of Ophthalmology |