Open Angle GlaucomaCoQunNCT03611530
CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma
A study testing Coqun® ophthalmic solution in people with Open Angle Glaucoma, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
This is a randomized, parallel arm, multicenter, double-blind trial. Patients with POAG will be randomized 1:1 ratio to receive: Prostaglandin analogue (PGA) monotherapy + CoQun® (Arm A) Prostaglandin analogue (PGA) monotherapy + Vehicle (Arm B) Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Coqun® ophthalmic solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteItaly
- Study dates
- 4 Sep 2017to 29 Apr 2022
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of POAG (monolateral or bilateral) with an IOP ranging from 17 to 21 mm Hg (at the last performed visit and confirmed at the baseline study visit) on treatment with a topical prostaglandin analogue (PGA) monotherapy.
- VF examination at randomization: VF Mean Defect (MD) at baseline within -4 decibel (dB) and -10dB and VF Pattern Standard Deviation (PSD) within 4 dB and 10dB (stage 2-3 per the Enhanced Glaucoma Staging System 2 (GSS) determined by Humphrey Field Analyzer II-i, program 30-2 SITA standard.
- In order to determine patient's reliability to perform VF examination: before baseline VF, at least two reliable VF examinations during the last year had to be performed. Visual fields are considered reliable if false-positive responses are fewer than 15% and a clear blind spot could be seen in the VF printouts, threshold value <10 dB.
- Age >40 years
- Provision of informed consent prior to any study specific procedures
Who cannot join
- Secondary glaucoma (exofoliative glaucoma, pigmentary glaucoma, neovascular glaucoma).
- Abnormalities of the anterior segment of the eye that could affect IOP assessment.
- Cornea abnormalities with entities that could affect IOP evaluation.
- Other conditions different from glaucoma that could cause VF abnormalities (degenerative myopia, diabetic retinopathy, maculopathy, other optic nerve abnormalities that could mimic glaucoma damage).
- BCVA) < 0.5 Snellen decimal fraction
- Any previous ocular surgery except for uncomplicated cataract extraction and YAG laser capsulotomy, laser glaucoma surgeries (argon laser trabeculoplasty and/or selective laser trabeculoplasty).
- Pregnancy or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Controlled Trial Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Patients Affected by Open-angle Glaucoma
This is a randomized, parallel arm, multicenter, double-blind trial.
Patients with POAG will be randomized 1:1 ratio to receive:
- Prostaglandin analogue (PGA) monotherapy + CoQun® (Arm A)
- Prostaglandin analogue (PGA) monotherapy + Vehicle (Arm B)
Read the detailed description
CoQun® 10 ml is a medical device marked by the European Community as class IIb. This device has a system of dispensation that permits it to be preservative free (OSD - Ophthalmic Squeeze Dispenser). Investigators and patients will be masked to the study treatment. In order to mask the treatment, identical kit boxes, identical packaging (bottles and labels) will be used for vehicle and active product. The bottles will be dispensed sealed to the patient.
One or two drops of the solution (CoQun® or Vehicle) will be instilled in the conjunctival sac of both eyes, twice daily from 8 to 10 AM and from 8 to 10 PM. Hypotensive therapy should be administered in the evening one hour after the CoQun® or Vehicle administration.
At baseline, ocular hypotensive treatment, as per inclusion criteria has to be a PGA monotherapy. During the follow-up, in case the IOP exceeds 28 mmHg, any additional hypotensive therapy will be allowed to obtain IOP control.
Dose modifications/reductions of CoQun® /Vehicle are not permitted.
- Conditions
- Open Angle Glaucoma
- Being tested
- Coqun® ophthalmic solution, Placebo ophthalmic solution
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coqun® ophthalmic solutionDevice
Also called Prostaglandin analogue (PGA) monotherapy
Prostaglandin analogue (PGA) monotherapy + Coqun® ophthalmic solution
Placebo ophthalmic solutionOther
Also called Prostaglandin analogue (PGA) monotherapy
Prostaglandin analogue (PGA) monotherapy + Placebo ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| CoQun® | Experimental | Patients in Arm A will be randomized to receive Prostaglandin analogue (PGA) monotherapy + CoQun®. CoQun® ophthalmic solution will be administered two times daily. CoQun® will be administered in addition to hypotensive therapy. Dose modifications for CoQun® are not permitted. Receives: Device: Coqun® ophthalmic solution |
| Placebo | Placebo comparator | Patients in Arm B will be randomized to receive Prostaglandin analogue (PGA) monotherapy +Placebo. Placebo ophthalmic solution will be administered two times daily. Placebo will be administered in addition to hypotensive therapy. Dose modifications for Placebo are not permitted. Receives: Other: Placebo ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression (TTP)
Time to Progression (TTP) defined as the time between baseline visit and the visit with the first evidence of progression in either eye is detected. When progression is detected, the progression should be confirmed at the two subsequent and consecutive Visual Field (VF) examinations.VF examinations will be assessed by an independent reading centre.
Measured: Randomization till VF progression, up to 36 months
Secondary outcomes (4)
Velocity of Visual Field (VF) loss
VF loss as determined by Guided Progression Analysis software (version 5.1.1) will be assessed at the last VF examination.
Measured: Randomization till VF progression, up to 36 months
Retinal Nerve Fiber Layer (RNFL) thickness
RNFL thickness by the means of OCT: change from baseline
Measured: Randomization till VF progression, up to 36 months
Intraocular pressure (IOP)
IOP change from baseline
Measured: Randomization till VF progression, up to 36 months
Best Correct Visual Acuity (BCVA)
BCVA change from baseline
Measured: Randomization till VF progression, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start4 Sep 2017
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Angle 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luciano Quaranta, MD PhD, Principal investigator, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611530
- Sponsor's protocol ID
- IRFMN-OG-7204
- Acronym
- CoQun
- Status last verified
- Mar 2024
- First submitted
- 4 Sep 2017
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quaranta L, Riva I, Biagioli E, Rulli E, Rulli E, Poli D, Legramandi L; CoQun(R) Study Group. Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Open-Angle Glaucoma Patients: A Study Protocol. Adv Ther. 2019 Sep;36(9):2506-2514. doi: 10.1007/s12325-019-01023-3. Epub 2019 Jul 12.
PubMed 31301054
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Controlled Trial Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Patients Affected by Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT03611530
- Acronym / sponsor ID
- CoQun / IRFMN-OG-7204
- Conditions
- Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 2 Aug 2018 (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.
This is a randomized, parallel arm, multicenter, double-blind trial.
Patients with POAG will be randomized 1:1 ratio to receive:
- Prostaglandin analogue (PGA) monotherapy + CoQun® (Arm A)
- Prostaglandin analogue (PGA) monotherapy + Vehicle (Arm B)
Detailed description
CoQun® 10 ml is a medical device marked by the European Community as class IIb. This device has a system of dispensation that permits it to be preservative free (OSD - Ophthalmic Squeeze Dispenser). Investigators and patients will be masked to the study treatment. In order to mask the treatment, identical kit boxes, identical packaging (bottles and labels) will be used for vehicle and active product. The bottles will be dispensed sealed to the patient.
One or two drops of the solution (CoQun® or Vehicle) will be instilled in the conjunctival sac of both eyes, twice daily from 8 to 10 AM and from 8 to 10 PM. Hypotensive therapy should be administered in the evening one hour after the CoQun® or Vehicle administration.
At baseline, ocular hypotensive treatment, as per inclusion criteria has to be a PGA monotherapy. During the follow-up, in case the IOP exceeds 28 mmHg, any additional hypotensive therapy will be allowed to obtain IOP control.
Dose modifications/reductions of CoQun® /Vehicle are not permitted.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoQun® | Experimental | Device: Coqun® ophthalmic solutionPatients in Arm A will be randomized to receive Prostaglandin analogue (PGA) monotherapy + CoQun®. CoQun® ophthalmic solution will be administered two times daily. CoQun® will be administered in addition to hypotensive therapy. Dose modifications for CoQun® are not permitted. |
| Placebo | Placebo comparator | Other: Placebo ophthalmic solutionPatients in Arm B will be randomized to receive Prostaglandin analogue (PGA) monotherapy +Placebo. Placebo ophthalmic solution will be administered two times daily. Placebo will be administered in addition to hypotensive therapy. Dose modifications for Placebo are not permitted. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with diagnosis of POAG (monolateral or bilateral) with an IOP ranging from 17 to 21 mm Hg (at the last performed visit and confirmed at the baseline study visit) on treatment with a topical prostaglandin analogue (PGA) monotherapy.
- VF examination at randomization: VF Mean Defect (MD) at baseline within -4 decibel (dB) and -10dB and VF Pattern Standard Deviation (PSD) within 4 dB and 10dB (stage 2-3 per the Enhanced Glaucoma Staging System 2 (GSS) determined by Humphrey Field Analyzer II-i, program 30-2 SITA standard.
- In order to determine patient's reliability to perform VF examination: before baseline VF, at least two reliable VF examinations during the last year had to be performed. Visual fields are considered reliable if false-positive responses are fewer than 15% and a clear blind spot could be seen in the VF printouts, threshold value <10 dB.
- Age >40 years
- Provision of informed consent prior to any study specific procedures
Key exclusion criteria (7 listed)
- Secondary glaucoma (exofoliative glaucoma, pigmentary glaucoma, neovascular glaucoma).
- Abnormalities of the anterior segment of the eye that could affect IOP assessment.
- Cornea abnormalities with entities that could affect IOP evaluation.
- Other conditions different from glaucoma that could cause VF abnormalities (degenerative myopia, diabetic retinopathy, maculopathy, other optic nerve abnormalities that could mimic glaucoma damage).
- BCVA) < 0.5 Snellen decimal fraction
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 |
|---|---|---|
| Coqun® ophthalmic solutionAlso: Prostaglandin analogue (PGA) monotherapyProstaglandin analogue (PGA) monotherapy + Coqun® ophthalmic solution | Device | CoQun® |
| Placebo ophthalmic solutionAlso: Prostaglandin analogue (PGA) monotherapyProstaglandin analogue (PGA) monotherapy + Placebo ophthalmic solution | Other | Placebo |
Primary outcome
Time to Progression (TTP)
Time frame: Randomization till VF progression, up to 36 months
Time to Progression (TTP) defined as the time between baseline visit and the visit with the first evidence of progression in either eye is detected. When progression is detected, the progression should be confirmed at the two subsequent and consecutive Visual Field (VF) examinations.VF examinations will be assessed by an independent reading centre.
4 secondary outcomes
Velocity of Visual Field (VF) loss
Time frame: Randomization till VF progression, up to 36 months
Retinal Nerve Fiber Layer (RNFL) thickness
Time frame: Randomization till VF progression, up to 36 months
Intraocular pressure (IOP)
Time frame: Randomization till VF progression, up to 36 months
Best Correct Visual Acuity (BCVA)
Time frame: Randomization till VF progression, up to 36 months
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 31301054Quaranta L, Riva I, Biagioli E, Rulli E, Rulli E, Poli D, Legramandi L; CoQun(R) Study Group. Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Open-Angle Glaucoma Patients: A Study Protocol. Adv Ther. 2019 Sep;36(9):2506-2514. doi: 10.1007/s12325-019-01023-3. Epub 2019 Jul 12.
- Individual participant dataSharing planned: No
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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.
Luciano Quaranta, MD PhD principal investigator
Università degli Studi di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coqun® ophthalmic solution in people with Open Angle Glaucoma, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: low accrual). Results are not available in the source record.
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?
Time to Progression (TTP) (time frame: Randomization till VF progression, up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03611530, which also lists 1 linked publication.
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 13 Mar 2024.