Clinical trial for effects of French maritime pine bark/bilberry fruit extracts on intraocular pressure for primary open angle glaucoma

Phase 3

Recruiting

• Conditions: Primary open-angle glaucoma or ocular hypertension

• Registration Number: JPRN-jRCTs061230051
• Lead Sponsor: Tanito Masaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1) Primary open-angle glaucoma including juvenile open-angle glaucoma and normal tension glaucoma or ocular hypertension in one or both eyes.
2) Glaucoma progression and ocular hypertension are controlled with no medication or three or fewer medications.
3) No need for eye surgery, including glaucoma, within the next 12 months in either eye.
4) At least one eye has an intraocular pressure of 15 mmHg or greater by Goldmann applanation tonometer under the use of glaucoma medication.
5) Self-measurement of intraocular pressure and blood pressure is possible.
6) Written informed consent.

Exclusion Criteria

1) Severe systemic illness.
2) Secondary glaucoma.
3) Other eye diseases leading to blindness, except glaucoma and mild cataracts.
4) Hepatic, renal, and cardiac disorders affecting assessment.
5) May cause allergic reactions to the test food.
6) May cause severe allergic reactions to other foods and medicines.
7) Continuous intake habits of antioxidant advocacy supplements (pine bark extract, bilberry, blackcurrant, lutein, astaxanthin, vitamin C, and vitamin E) in the 6 months before enrolment or planned to do so during the study period.
8) Lifestyle changes may be made during the study period (e.g. extended travel, change of diet).
9) Pregnant, lactating, or possibly pregnant.
10) Participation in another human clinical trial at the time of consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraocular pressure by Goldmann tonometer

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure by self-measurement, Blood pressure and Pulse by self-measurement, Blood oxidative stress markers, Carotenoids, Advanced Glycation End Products, Autonomic balance, Adverse events