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

JRCT ID: jRCTs061230051

Registered date:21/08/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Primary open-angle glaucoma or ocular hypertension
• Date of first enrollment: 29/08/2023
• Target sample size: 24
• Study type: Interventional

Intervention(s)

Participants are randomly assigned 1:1 to GP or PG group.
GP group: take French maritime pine bark/bilberry fruit extracts for 8 weeks, followed by placebo for 8 weeks.
PG group: take placebo for 8 weeks, followed by 8 weeks of French maritime pine bark/bilberry fruit extracts.
Both foods are taken one tablet per day. There are no washout periods when switching foods.

Outcome(s)

• Primary Outcome: Intraocular pressure by Goldmann tonometer
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 70age old
• Gender: Both

Include 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 (in the case of combination drugs, no more than five active ingredients).
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.

Exclude 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.

Related Information

• Primary Sponsor: Tanito Masaki