NCT05275738

The Glaucoma Nicotinamide Trial

The Glaucoma Nicotinamide Trial - A Prospective, Randomized, Placebo-controlled, Double-masked Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The Glaucoma Nicotinamide Trial (TGNT) is a prospective, randomized, placebo-controlled double-masked clinical trial composed of two cohorts; The Swedish Glaucoma Nicotinamide Trial (SGNT) and the Vitamin B3 In Glaucoma Study (VBIGS). Patients with open-angle glaucoma (OAG) will be randomized to receive either Nicotinamide or placebo through block randomization stratified by glaucoma subtype with a 1:1 allocation.

Detailed description

The treatment arms that included patients will be randomized into are either Nicotinamide tablets 1.5g for 6 weeks and then 3.0g onwards or true placebo tablets. A major difference between the SGNT and VBIGS is that in SGNT untreated newly diagnosed glaucoma patients will be included whereas in VBIGS glaucoma patients with intraocular pressure lowering treatment will be included. Also, in SGNT an additional non-blinded arm with healthy subjects will receive Nicotinamide tablets 1.5g for 6 weeks and then 3.0g onwards. For participants where both eyes are eligible, both will be included. The primary endpoint is visual field progression change over two years.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nicotinamide	Study tablets for nicotinamide are produced by Blackmores Ltd.
OTHER	Placebo	Study tablets for placebo are produced by Blackmores Ltd.

Timeline

• Start date: 2022-05-18
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-03-11
• Last updated: 2023-07-27

Locations

2 sites across 1 country: Sweden