Effectiveness of citicoline on visual field preservation in patients with open angle glaucoma
Research type
Research Study
Full title
A phase III multicenter, double-blind, randomized, placebo-controlled, parallel-group trial of the efficacy of citicoline eye drops 2% on visual field preservation in patients with open angle glaucoma
IRAS ID
1007652
Contact name
Daniel Semere
Contact email
Sponsor organisation
Omikron Italia S.R.L
Clinicaltrials.gov Identifier
Research summary
Glaucoma is a chronic (long-term) worsening eye disease caused by increased pressure within the eyes, leading to damage of the eye nerves and vision loss. Standard treatments act to lower the pressure in the eyes and prevent damage to the eye nerves. Citicoline acts as a protective agent to nerves by slowing and preventing the death of nerve cells. The purpose of this study is to assess the ability of Citicoline 20mg/ml (2%) eye drops solution to prevent further damage to the eye nerves in glaucoma, and thus delay worsening of vision loss. This will be assessed by looking at effects on the visual field (the area one can see whilst the eye is focused on a single point). The trial will also assess the safety of using citicoline 20mg/ml eye drops.
The study is randomized and double-blind. There are 2 treatment groups; citicoline 2% eye drops and a visually-identical dummy eye drops solution containing no active agent. Participants are randomly allocated to one of the groups, and neither they nor the study clinician or team will know which eye drops are being given.
Participants will drop one drop into the study eye (as chosen by the study doctor based on the eye assessments) three times a day, daily for up to 36 months (3 years). Participants will be asked to keep a diary to record when they use their eye drops. Participants will be asked to attend their eye clinic at regular intervals to have eye examinations including visual field assessments performed during the 3 years study duration to see how their glaucoma is progressing and whether the visual field is deteriorating or not over time.REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0548
Date of REC Opinion
29 Apr 2024
REC opinion
Further Information Favourable Opinion