GlaucomaNCT04020705
The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma
A study testing Citicoline eye drops (OMK1) in people with Glaucoma, run by Istituto di Ricerca Neuroftalmologia S.r.l..
Trial summary
Double-blind study (OMK1 vs. Placebo) A total of 90 patients, 30 per center, will be the study sample. The study will include patients with Primary Open angle Glaucoma (glaucoma or pseudoexfoliation) with a loss of visual field with MD between -2 dB and -15 decibel. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Citicoline eye drops (OMK1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2015to 19 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with POAG and pseudoexfoliation glaucoma in one or both eyes. In the latter case, only one eye (chosen at random) will be used for the analysis.
- Patients with -2 < MD < -15 dB, progression of MD at least -0,5 dB/y for 2 years.
- Patients with tonometric compensation, i.e., IOP not above 18 mmHg. Tonometric compensation can be achieved with any type of hypotonic medical therapy and must be maintained during the 3 years of the study. If at any check-up the average of at least 3 measurements of IOP at different times is higher than 18 mmHg, the patient will be offered a new hypotonic treatment (including surgery) to control the progression of the disease. If compensation cannot be achieved (e.g., the patient refuses the proposed therapy or, in spite of this does not achieve satisfactory IOP values), the patient will be excluded from the study.
- Patients over the age of 18 years
Who cannot join
- Patients with contraindications to citicoline
- Patients with IOP higher than 18 mmHg
- Patients with other forms of glaucoma
- Patients treated with other neuroprotective therapies
- Women who are pregnant and/or breastfeeding
- Pediatric or adolescent patients aged under 18 years
About this study
Double-blind study (OMK1 vs. Placebo) A total of 90 patients, 30 per center, will be the study sample. The study will include patients with Primary Open angle Glaucoma (glaucoma or pseudoexfoliation) with a loss of visual field with MD between -2 dB and -15 decibel.
Patients will be randomized into 2 treatment groups, both treated with hypotonic ocular drug therapy: one part of the patients will be treated with the OMK1 Medical Device containing topical citicoline for 3 years; the remaining part will receive a placebo.
Read more
All patients will be followed with quarterly visits which will check, in addition to the intraocular pressure (IOP), the structure of the optic nerve and visual function (standard visual field).
The primary objective is to evaluate a reduction of the perimetric progression in the group that receives the topical citicoline compared to the group treated with placebo. The reduction of the progression will be evaluated with Spectral Domain Optic coherence tomography and with standard perimetry (SAP).
The secondary objective is to assess the tolerability and safety of OMK1 eye drops.
- Conditions
- Glaucoma
- Being tested
- Citicoline eye drops (OMK1), Placebo Comparator: hypromellose based ocular lubricant
- Keywords
- Glaucoma, Glaucoma Open Angle, Pseudoexfoliation Glaucoma
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citicoline eye drops (OMK1)Device
(OMK1) will be prescribed in the dosage of 1 drop 3 times a day
Placebo Comparator: hypromellose based ocular lubricantOther
will be prescribed in the dosage of 1 drop 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Citicoline eye drops (OMK1) | Experimental | 45 patients will be treated with active treatment (OMK1) Receives: Device: Citicoline eye drops (OMK1) |
| hypromellose based ocular lubricant | Placebo comparator | 45 patients will be treated with placebo (lubricant eye drops) Receives: Other: Placebo Comparator: hypromellose based ocular lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glaucomatous damage
The primary objective of the study is to assess whether there is a difference in the deterioration of glaucomatous damage with standard perimetry (HFA 24-2 and 10-2) in the group that receives the topical citicoline in addition to topical therapy with hypotensive drugs compared to the group treated with the sole reduction of intraocular pressure.
Measured: Baseline and Visit at 36 months
Secondary outcomes (1)
progression of glaucoma in the SD OCT examination
assessment of the progression of glaucoma in the SD OCT examination (Retinal Nerve fiber Layer- RNFL evaluation) in the group that receives the topical citicoline together with ocular antihypertensive drug therapy compared to the group treated with the sole reduction of intraocular pressure.
It will be used for the assessment of the progression of glaucoma the Brusini staging system.
Measured: Baseline and Visit at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start22 Sep 2015
- Primary completion19 Mar 2019
- Study completion19 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto di Ricerca Neuroftalmologia S.r.l.
- Sponsor type
- Research network
- Collaborators
- University of Milan
- Responsible party
- Principal investigator, Luca Rossetti, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020705
- Sponsor's protocol ID
- OMK20115
- Status last verified
- Jul 2019
- First submitted
- 12 Apr 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma
- ClinicalTrials.gov ID
- NCT04020705
- Acronym / sponsor ID
- OMK20115
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Glaucoma Open Angle, Pseudoexfoliation Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istituto di Ricerca Neuroftalmologia S.r.l.Research network
- Collaborators
- University of Milan
- Study start
- 22 Sep 2015 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blind study (OMK1 vs. Placebo) A total of 90 patients, 30 per center, will be the study sample. The study will include patients with Primary Open angle Glaucoma (glaucoma or pseudoexfoliation) with a loss of visual field with MD between -2 dB and -15 decibel.
Patients will be randomized into 2 treatment groups, both treated with hypotonic ocular drug therapy: one part of the patients will be treated with the OMK1 Medical Device containing topical citicoline for 3 years; the remaining part will receive a placebo.
All patients will be followed with quarterly visits which will check, in addition to the intraocular pressure (IOP), the structure of the optic nerve and visual function (standard visual field).
The primary objective is to evaluate a reduction of the perimetric progression in the group that receives the topical citicoline compared to the group treated with placebo. The reduction of the progression will be evaluated with Spectral Domain Optic coherence tomography and with standard perimetry (SAP).
The secondary objective is to assess the tolerability and safety of OMK1 eye drops.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citicoline eye drops (OMK1) | Experimental | Device: Citicoline eye drops (OMK1)45 patients will be treated with active treatment (OMK1) |
| hypromellose based ocular lubricant | Placebo comparator | Other: Placebo Comparator: hypromellose based ocular lubricant45 patients will be treated with placebo (lubricant eye drops) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with POAG and pseudoexfoliation glaucoma in one or both eyes. In the latter case, only one eye (chosen at random) will be used for the analysis.
- Patients with -2 < MD < -15 dB, progression of MD at least -0,5 dB/y for 2 years.
- Patients with tonometric compensation, i.e., IOP not above 18 mmHg. Tonometric compensation can be achieved with any type of hypotonic medical therapy and must be maintained during the 3 years of the study. If at any check-up the average of at least 3 measurements of IOP at different times is higher than 18 mmHg, the patient will be offered a new hypotonic treatment (including surgery) to control the progression of the disease. If compensation cannot be achieved (e.g., the patient refuses the proposed therapy or, in spite of this does not achieve satisfactory IOP values), the patient will be excluded from the study.
- Patients over the age of 18 years
Key exclusion criteria (6 listed)
- Patients with contraindications to citicoline
- Patients with IOP higher than 18 mmHg
- Patients with other forms of glaucoma
- Patients treated with other neuroprotective therapies
- Women who are pregnant and/or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citicoline eye drops (OMK1)(OMK1) will be prescribed in the dosage of 1 drop 3 times a day | Device | Citicoline eye drops (OMK1) |
| Placebo Comparator: hypromellose based ocular lubricantwill be prescribed in the dosage of 1 drop 3 times a day | Other | hypromellose based ocular lubricant |
Primary outcome
Change in glaucomatous damage
Time frame: Baseline and Visit at 36 months
The primary objective of the study is to assess whether there is a difference in the deterioration of glaucomatous damage with standard perimetry (HFA 24-2 and 10-2) in the group that receives the topical citicoline in addition to topical therapy with hypotensive drugs compared to the group treated with the sole reduction of intraocular pressure.
1 secondary outcome
progression of glaucoma in the SD OCT examination
Time frame: Baseline and Visit at 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Citicoline eye drops (OMK1) in people with Glaucoma, run by Istituto di Ricerca Neuroftalmologia S.r.l..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glaucomatous damage (time frame: Baseline and Visit at 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.