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.

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. - Japanese Normal Tension Glaucoma Treatment Study (JNTGTS)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000422

Enrollment

150

Registered

2006-05-25

Start date

2002-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Tension Glaucoma

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with normal-tension glaucoma in one eye or both eyes who meet the following criteria: 1)Untreated intraocular pressure at visit is 18 mmHg or less 2)MD values measured using the Humphrey Field Analyzer C30-2 are -15.0 dB or higher in both eyes 3)At least one of the eyes meets the following criteria regarding the visual field: (1)MD value is -12.0 dB or higher (2)Meets Caprioli's criteria for "moderate" -Male and female subjects between 20 and 60 years of age

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
-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	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026