Actively Recruiting
Efficacy of Citicoline Eye Drops 2% on Visual Field Preservation in Patients With Open Angle Glaucoma
Led by Omikron Italia S.r.l. · Updated on 2024-03-12
1000
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
Sponsors
O
Omikron Italia S.r.l.
Lead Sponsor
O
OPIS Spain
Collaborating Sponsor
AI-Summary
What this Trial Is About
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%
CONDITIONS
Official Title
Efficacy of Citicoline Eye Drops 2% on Visual Field Preservation in Patients With Open Angle Glaucoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Age 18 years or older
- Diagnosis of open-angle, pseudoexfoliation, or pigmentary glaucoma
- Best corrected visual acuity of 0.5 or better in the study eye
- Controlled intraocular pressure of 18 mmHg or less in the study eye (average of last 3 clinic measurements)
- Visual field mean deviation not worse than -12 dB in the study eye
- Evidence of visual field deterioration with mean deviation declining between -0.5 dB/year and -1.0 dB/year, based on at least 4 recent visual field tests
- Glaucoma diagnosis based on visual field damage and optic nerve head changes; if both eyes qualify, the one with better mean deviation is selected
- Women of childbearing potential agree to use effective contraception
You will not qualify if you...
- Cataract in the study eye that may require surgery within the next three years
- Patients with only one functional eye (visual acuity less than 0.1 in one eye or significant central visual field loss)
- Known allergy or intolerance to any ingredients in the eye drops
- Diode laser treatment or glaucoma surgery within the past 2 years, or cataract surgery within the last 6 months in the study eye
- Any glaucoma type other than primary, pseudoexfoliative, or pigmentary open-angle glaucoma
- Other eye or systemic diseases that could affect visual field or test performance
- Current use of topical or systemic citicoline treatment
- Use of other neuroprotective treatments unwilling to stop and undergo a 6-month washout period before the study
- Inability to perform reliable visual field tests (false positive rate above 15% in recent tests)
- Pregnancy or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Presidio Ospedale San Paolo
Milan, MI, Italy, 20142
Actively Recruiting
Research Team
C
Carla Russo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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