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

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

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

Treatments tested in this trial

  • Citicoline eye drops 2%
  • Placebo

Treatment groups

1,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Omikron Italia S.r.l.

Lead sponsor

OPIS Spain

Collaborator