Health TrialsbyHealthPanel

Efficacy of Citicoline Eye Drops 2% on Visual Field Preservation in Patients With Open Angle Glaucoma

ConditionGlaucoma, Open-Angle
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOmikron Italia S.r.l.

About this trial

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%

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed written informed consent.

Age ≥ 18 years.

Eyes with OAG, Pseudoexfoliation and pigmentary glaucoma will be included.

Best Corrected Visual Acuity (BCVA) ≥ 0.5 for the study eye.

Disqualifiers

Cataract in the study eye which, in the opinion of the clinician, may require cataract surgery within the next three years.

Only-eye patients (visual acuity < 0.1 decimals in one eye or more than two paracentral VF locations with a sensitivity of < 10 dB).

Known intolerance or allergy to any of the components in the eye drops.

Diode laser treatment or glaucoma surgery in the past 2 years or cataract surgery within the last 6 months in the study eye.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Citicoline eye drops 2%

    Drug

    Eye drops containing Citicoline 2%

  • Placebo

    Drug

    Eye drops containing placebo matching product

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: citicoline eye drops 2%Experimental treatment 1 intervention
Group B: Placebo eye dropsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression of visual field damage

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.

Time frame
3 years

Secondary outcomes

1

Rate of progression in structural parameters

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).

Time frame
3 years
2

Safety (IOP)

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

Time frame
3 years
3

Visual Field recovery

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).

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Omikron Italia S.r.l.

Lead sponsor

OPIS Spain

Collaborator

Source ClinicalTrials.gov
Apply now