A phase III multicenter, double-blind, randomized, placebo-controlled, parallel-group trial of the efficacy of citicoline eyedrops 2% on visual field preservation in patients with open angle glaucoma

The primary objective of this phase III multicenter, double-blind, randomized, placebo-controlled, parallel-group trial is to determine whether **citicoline** eye drops 2% are superior to placebo in reducing visual field (VF) deterioration in patients with progressing open angle **glaucoma** (OAG) who are treated according to best clinical practice. This is clinically relevant as it aims to establish an effective treatment option for preserving visual function in individuals with OAG, a condition that can lead to irreversible vision loss.

Secondary objectives include the evaluation of the effect of citicoline eye drops 2% on changes in structural parameters and the confirmation of the safety profile of citicoline eye drops 2%. These objectives are crucial for understanding the broader impact of citicoline on ocular health and ensuring its safety for long-term use in patients with glaucoma.

The clinical trial involves a total of **50 participants** diagnosed with **glaucoma**, specifically focusing on individuals with progressing open-angle glaucoma (OAG). The study population includes both male and female subjects, aged 18 years and older, who are in general good health with controlled intraocular pressure (IOP) and a Best Corrected Visual Acuity (BCVA) of at least 0.5 in the study eye. Participants were selected based on specific criteria, including the presence of a reproducible glaucomatous visual field defect and corresponding damage to the optic nerve head, as well as the absence of other conditions that could account for visual field loss. The trial does not specify particular lifestyle considerations such as diet or physical activity. However, women of childbearing potential are required to use a highly effective method of contraception during the study and for 90 days after the last dose of treatment. The trial includes a vulnerable population, ensuring comprehensive ethical considerations are in place.

The clinical trial is a **phase III**, multicenter, double-blind, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy of **citicoline** eye drops 2% in preserving the visual field in patients with open-angle **glaucoma**. The primary objective is to determine whether citicoline eye drops are superior to placebo in reducing visual field deterioration in patients with progressing open-angle glaucoma treated according to best clinical practice. The trial is expected to last approximately three years, with an estimated end date of December 30, 2026.

Participants will be randomly assigned to receive either citicoline eye drops or placebo eye drops. The study will include several key visits: an initial screening visit to confirm eligibility, regular follow-up visits to monitor progress, and an end-of-study visit to assess outcomes. The inclusion criteria require participants to be 18 years or older, have a best-corrected visual acuity of at least 0.5 in the study eye, and have controlled intraocular pressure. Exclusion criteria are not specified in the provided data.

The primary endpoint is the rate of change in the mean deviation (MD) of the study eye, which is an index of the global deviation from age-corrected normal values. Secondary endpoints include differences in the rate of change of structural thickness, specifically the peripapillary retinal nerve fiber layer and macular thickness of the inner retina, evaluated by spectral-domain optical coherence tomography (SD-OCT).

Participants are expected to be involved in the study for the entire duration unless conditions arise that necessitate early termination, such as adverse events or withdrawal of consent. The study is not categorized as low intervention, and the trial phase is identified as phase III. The trial aims to provide robust data on the efficacy of citicoline eye drops in the management of glaucoma, contributing to the optimization of treatment strategies for this condition.

The clinical trial involves the administration of **Citicoline** eye drops, which are formulated as a 2% solution. The active substance in this experimental medication is **citicoline sodium**, a chemical compound. The pharmaceutical form of the medication is eye drops, and it is administered via the ocular route. Participants in the trial will receive a maximum daily dose of 60 mg/ml, with the treatment period extending up to 36 months. The eye drops are manufactured by OMIKRON ITALIA S.R.L. and are intended to assess their efficacy in preserving the visual field in patients with open-angle glaucoma.

In addition to the experimental treatment, a **placebo** is used as a comparator in this double-blind, randomized, placebo-controlled trial. The placebo eye drops consist of a vehicle containing hyaluronic acid at a concentration of 0.02 g, benzalkonium chloride at 0.001 g, and water for injection up to 10 ml. The placebo is also administered as eye drops, following the same route and frequency as the experimental medication. The placebo serves to ensure the validity of the trial results by providing a baseline for comparison against the effects of the citicoline eye drops.

The efficacy of citicoline eye drops 2% in patients with **open angle glaucoma** will be assessed through a phase III multicenter, double-blind, randomized, placebo-controlled, parallel-group trial. The primary endpoint for evaluating efficacy is the rate of change in mean deviation (MD) in the study eye, which serves as an index of the global deviation from age-corrected normal values. This endpoint aims to assess the difference in the rate of progression over a 3-year period between the experimental arm and the control arm.

Secondary endpoints include the rate of change in structural thickness, specifically the peripapillary Retinal Nerve Fibre Layer (RNFL) and macular thickness of the inner retina. These will be evaluated using Optical Coherence Tomography (OCT) and Spectral Domain Optical Coherence Tomography (SD-OCT) to measure the RNFL, Ganglion Cell Layer, and Ganglion Cell + Inner Plexiform Layer complex. These assessments will provide additional insights into the structural changes associated with the treatment.