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Study on the Effectiveness of Citicoline Eye Drops for Visual Field Preservation in Patients with Open Angle Glaucoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for glaucoma, a condition that affects the eyes and can lead to vision loss. The treatment being tested is citicoline eye drops, which are being compared to placebo eye drops. The main goal of the study is to determine if citicoline eye drops can better preserve the visual field, which is the area a person can see, in patients with open-angle glaucoma, a common type of glaucoma where the drainage angle for eye fluid remains open.

Participants in the study will receive either the citicoline eye drops or placebo eye drops. The study will last for a period of three years, during which the participants' eye health and vision will be monitored regularly. The study aims to see if there is a difference in how the vision changes over time between those using citicoline and those using placebo. The researchers will also look at changes in the thickness of certain layers of the retina, the light-sensitive tissue at the back of the eye, using a method called Optical Coherence Tomography (OCT).

This study is important for understanding whether citicoline eye drops can help slow down the progression of vision loss in people with open-angle glaucoma. By comparing the effects of citicoline to placebo, researchers hope to find a more effective way to manage this eye condition and improve the quality of life for those affected by it.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive citicoline eye drops and the other will receive placebo eye drops. This process is called randomization and ensures that the study results are unbiased.

  2. Step 2

    Medication administration

    If you are in the group receiving citicoline eye drops, you will be instructed to administer the drops at a concentration of 2% into the affected eye. The exact dosage and frequency will be provided by the study team.

    If you are in the group receiving placebo eye drops, you will administer drops that do not contain the active ingredient. These drops will contain hyaluronic acid, benzalkonium chloride, and water for injection.

  3. Step 3

    Regular check-ups

    Throughout the study, you will attend regular check-ups to monitor your eye health and the progression of your glaucoma. These check-ups will include tests to assess your visual field and the thickness of certain layers in your eye.

  4. Step 4

    Study duration

    The study will last for approximately three years. During this time, you will continue to use the eye drops as instructed and attend all scheduled appointments.

  5. Step 5

    End of study

    At the end of the study, your participation will conclude. The study team will analyze the data collected to determine the effectiveness of the citicoline eye drops in preserving the visual field in patients with glaucoma.

Who can join the trial?

9 criteria

  • Must provide signed written consent to participate.
  • Must be at least 18 years old.
  • Must have a type of glaucoma called Open Angle Glaucoma (OAG), or similar types like Pseudoexfoliation and pigmentary glaucoma.
  • Must have a Best Corrected Visual Acuity (BCVA) of at least 0.5 in the eye being studied. This means your vision can be corrected to a certain level with glasses or contact lenses.
  • Must have controlled Intraocular Pressure (IOP) of 18 mmHg or less in the eye being studied. This is the pressure inside your eye, and it should be within a certain range.
  • Must have a Visual Field (VF) Mean Deviation (MD) not worse than -12 dB in the eye being studied. This is a measure of your peripheral vision.
  • Must have specific glaucomatous changes in the Optic Nerve Head (ONH), which is the part of the eye where the optic nerve connects to the retina. These changes are identified through eye exams and imaging tests.
  • If both eyes are eligible, the eye with the better MD will be chosen for the study.
  • Women who can have children must agree to use a highly effective method of birth control during the study and for up to 90 days after the last dose of treatment.

Who cannot join the trial?

5 criteria

  • Patients who do not have open angle glaucoma. This is a common type of eye condition where the drainage angle for eye fluid is open, but the fluid passes too slowly.
  • Patients who are not experiencing worsening of their glaucoma condition.
  • Patients who are not being treated according to the best clinical practices for glaucoma.
  • Patients who are outside the specified age range for the study.
  • Patients who belong to a vulnerable population that the study is not designed to include.
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Investigated drugs

Citicoline is a medication used in this clinical trial in the form of eye drops. It is being tested to see if it can help protect the vision of people with open angle glaucoma, a condition that can lead to vision loss. The trial aims to find out if these eye drops can slow down the worsening of the visual field, which is the area a person can see around them when looking straight ahead. Citicoline is thought to support nerve cells in the eye, potentially helping to preserve vision in patients with this type of glaucoma.

What is already known about the treatment

Citicoline – Citicoline is administered in the form of eye drops, specifically at a 2% concentration, and is applied directly to the eyes. It is currently being studied in clinical trials to assess its effectiveness in preserving the visual field in patients with open-angle glaucoma, a common eye condition that can lead to vision loss. The main therapeutic indication for citicoline in this context is to slow down the progression of visual field deterioration in glaucoma patients. At the molecular level, citicoline is believed to support nerve cell health and function, potentially protecting the optic nerve from damage. It is classified pharmacologically as a neuroprotective agent.

Investigated diseases

Glaucoma – Glaucoma is a group of eye conditions that damage the optic nerve, which is crucial for good vision. This damage is often caused by abnormally high pressure in the eye. Open-angle glaucoma, the most common form, progresses slowly and painlessly, often without noticeable symptoms until significant vision loss occurs. As the disease advances, peripheral vision is typically affected first, leading to tunnel vision if untreated. Over time, the damage can lead to complete vision loss. The progression of glaucoma can vary, with some individuals experiencing rapid deterioration while others may have a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502273-42-00Protocol codeOMK1P3Estimated enrolment1 000 patientsSponsorOmikron Italia S.r.l.

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