> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-of-citicoline-eye-drops-2-on-visual-field-c408b658-a93a-4e9b-935c-dc31dbff7571 > Record changed: 2026-10-13 # Efficacy of Citicoline Eye Drops 2% on Visual Field Preservation in Patients With Open Angle Glaucoma NCT05710198 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) Participants 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) Lead sponsor Omikron Italia S.r.l. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) Start date 2023-12-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) ## Title and summary **Summary** To evaluate the efficacy of citicoline eye drops 2% in reducing visual field deterioration in patients with progressing OAG treated according to best clinical practice. Secondary objectives are assessing the effect of citicoline eye drops 2% on changes in structural parameters measured by Spectral Domain Optical Coherence Tomography (SD-OCT) and evaluating the safety of citicoline eye drops 2% Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Short title** Efficacy of Citicoline Eye Drops 2% on Visual Field Preservation in Patients With Open Angle Glaucoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) ## Dates **Completion date** 2027-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **First posted** 2023-02-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Registry last updated** 2024-03-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Primary completion date** 2026-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Start date** 2023-12-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) ## Size and sites **Participants** 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Planned participants** 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Lead sponsor** Omikron Italia S.r.l. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) ## Identifiers **Registry ID** NCT05710198 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **ClinicalTrials.gov ID** NCT05710198 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masking description** Double-blind **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) ## Outcomes ### Primary outcomes 1. Progression of visual field damage Timeframe: 3 years Difference in the rate of progression of VF damage in the study eye between the two trial arms. This will be measured with repeated, planned visual field (VF) tests, all performed with a Humphrey Field Analyser (HFA, Zeiss Meditec, Dublin, CA) with the SITA Standard 24-2 strategy, over the span of three years. ### Secondary outcomes 1. Rate of progression in structural parameters Timeframe: 3 years Difference in the rate of progression in structural parameters. These parameters focus on the ocular structures mostly damaged by glaucoma. The parameters of interest will be: \* RNFL thickness measured with Optical Coherence Tomography (OCT). \* Inner retina thickness in the macula (RNFL, Ganglion Cell Layer and Ganglion Cell + Inner Plexiform Layer complex). 2. Safety (IOP) Timeframe: 3 years Safety will be assured by regular assessments of adverse events and IOP. IOP will be carefully monitored and managed as per standard clinical practice (detailed management of IOP is reported later). Side effects from the neuroprotective drops or any IOP lowering treatment, including allergic reactions, ocular surface toxicity and signs of extraocular or intraocular inflammation, will be carefully assessed by the examiners and reported in the case report form (CRF). Any significant discomfort or adverse reactions to the drops or clear signs of inflammation will be reasons for early withdrawal 3. Visual Field recovery Timeframe: 3 years Evidence of neuro-recovery. The Visual field Mean Deviation values (2 tests) at Visit 2 will be compared between the two groups, after adjusting for the MD values at Visit 1 (baseline, 2 tests). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Signed written informed consent. 2. Age ≥ 18 years. 3. Eyes with OAG, Pseudoexfoliation and pigmentary glaucoma will be included. 4. Best Corrected Visual Acuity (BCVA) ≥ 0.5 for the study eye. 5. Controlled IOP (≤ 18 mmHg, average of the last 3 measurements in the clinic) in the study eye. 6. Visual field MD not worse than -12 dB at the latest assessment in the clinic for the study eye. 7. Deteriorating MD at a rate between -0.5 dB/year and -1.0 dB/year, estimated from the latest VF tests collected in the clinic (at least 4) over a period during which incisional glaucoma surgery was not performed. Combinations of SITA Standard and Fast strategies (but not SITA Faster) is admissible. Patients who reach the desired minimum number of tests (4) with a mixture of SITA Standard/Fast and SITA Faster tests will need to perform additional replacement tests according to the prevalent strategy used in their series of VF (i.e. additional SITA Standard/Fast tests if ≤ 2 tests were SITA Faster; additional SITA Faster if > 2 tests were SITA Faster). 8. Glaucoma definition will be based on VF damage (24-2, any SITA strategy) and spatially congruent glaucomatous changes at the ONH. If both eyes are eligible, the eye with the better MD will be chosen as the study eye. 9. Women of childbearing potential willing to use an appropriate method of contraception. ### Exclusion criteria 1. Cataract in the study eye which, in the opinion of the clinician, may require cataract surgery within the next three years. 2. Only-eye patients (visual acuity < 0.1 decimals in one eye or more than two paracentral VF locations with a sensitivity of < 10 dB). 3. Known intolerance or allergy to any of the components in the eye drops. 4. Diode laser treatment or glaucoma surgery in the past 2 years or cataract surgery within the last 6 months in the study eye. 5. Eyes with any type of glaucoma other than primary, pseudoexfoliative or pigmentary OAG. 6. Patients with other ocular or systemic comorbidities that, in the opinion of the Investigator, might affect the VF or the execution of the test. 7. Patients already on topical or systemic citicoline treatment. 8. Patients taking other systemic or topical potential neuroprotectors competing with citicoline eye drops 2% (a list will be provided) unwilling to suspend these treatments and undergo a washout period of 6 months prior to the study. 9. Patients unable to perform reliable VF tests, based on the assessment of the last 4 available 24-2 Humphrey Field Analyzer (HFA) VF tests performed in the clinic with a false positive rate (FP) ≤ 15%. 10. Pregnant and nursing patients. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) ## Sites - Presidio Ospedale San PaoloMilan, ItalyRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) ## References - PubMed 41599168 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41599168/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05710198) ## Related records ### Drugs (1) - [Citicoline](https://trialight.com/data/asset/citicoline-f5938bef-5da4-4d58-8885-c4ba9dd1cf3c.md) ### Collaborators (1) - OPIS Spain ### Lead sponsors (1) - [Omikron Italia S.r.l.](https://trialight.com/data/company/omikron-italia-s-r-l-6dec0940-376a-40d1-bb33-296581139199.md) ### Conditions (2) - [Glaucoma](https://trialight.com/data/condition/glaucoma-7a3c05c0-9871-55db-af74-962761181784.md) - [Open-angle glaucoma](https://trialight.com/data/condition/open-angle-glaucoma-fb887921-4122-599b-b8a0-928b40ddc7a2.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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