Phase 3 Glaucoma Trial, Recruiting NCT05710198 Sponsor: Omikron Italia S.r.l. Condition: Glaucoma
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Phase 3 Glaucoma Trial, Recruiting

NCT05710198
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older who have signed a consent form agreeing to take part in the trial.
  • People diagnosed with open-angle glaucoma, pseudoexfoliation glaucoma, or pigmentary glaucoma.
  • People whose vision in the study eye, when corrected with glasses or contact lenses, meets a minimum level of sharpness (confirm with trial site for exact threshold).
  • People whose eye pressure in the study eye is well controlled, averaging 18 mmHg or below across the last three clinic measurements.
  • People whose visual field (side and peripheral vision) test results show a loss no worse than -12 dB at their most recent assessment.
  • People whose visual field loss is progressing slowly, at a rate of between -0.5 and -1.0 dB per year, based on at least 4 visual field tests taken during a period when no glaucoma surgery was performed.
  • People whose glaucoma diagnosis is confirmed by both visual field test results and matching changes seen at the back of the eye (the optic nerve head).
  • Women who could become pregnant and are willing to use a suitable method of contraception during the trial.

Who may not be able to join:

  • People who have a cataract in the study eye that a clinician believes is likely to need surgery within the next three years.
  • People who effectively have only one functioning eye — defined as having very poor vision or significant blind spots in one or more eyes (confirm with trial site for exact definition).
  • People with a known allergy or intolerance to any ingredient in the eye drops being studied.
  • People who have had laser treatment for glaucoma or glaucoma surgery in the past 2 years, or cataract surgery in the past 6 months, in the study eye.
  • People whose glaucoma is of a type other than open-angle, pseudoexfoliation, or pigmentary glaucoma.
  • People with other eye or general health conditions that, in the investigator's opinion, might affect vision test results or the ability to complete the trial.
  • People who are already using citicoline treatment, either as eye drops or taken orally or by another systemic route.
  • People currently taking other treatments (topical or systemic) that may have a similar protective effect on the optic nerve, who are not willing to stop those treatments and complete a 6-month washout period before the trial begins.
  • People who are unable to produce reliable visual field test results, based on their last 4 visual field tests showing an error rate above 15%.
  • People who are pregnant or currently breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +39 06 80693572

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Omikron Italia S.r.l.
Registry
ClinicalTrials.gov
Start date
11 December 2023
Est. completion
1 April 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Progression of visual field damage

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov