- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03611530
CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma (CoQun)
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)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elena Biagioli, Pharm. D
- Phone Number: 0039 02 3901 4650
- Email: elena.biagioli@marionegri.it
Study Contact Backup
- Name: Erica Rulli
- Phone Number: 0039 02 3901 4684
- Email: erica.rulli@marionegri.it
Study Locations
-
-
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Brescia, Italy
- Università degli Studi di Brescia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CoQun®
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.
|
Prostaglandin analogue (PGA) monotherapy + Coqun® ophthalmic solution
Other Names:
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Placebo Comparator: Placebo
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.
|
Prostaglandin analogue (PGA) monotherapy + Placebo ophthalmic solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Randomization till VF progression, up to 36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Velocity of Visual Field (VF) loss
Time Frame: Randomization till VF progression, up to 36 months
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VF loss as determined by Guided Progression Analysis software (version 5.1.1)
will be assessed at the last VF examination.
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Randomization till VF progression, up to 36 months
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Retinal Nerve Fiber Layer (RNFL) thickness
Time Frame: Randomization till VF progression, up to 36 months
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RNFL thickness by the means of OCT: change from baseline
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Randomization till VF progression, up to 36 months
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Intraocular pressure (IOP)
Time Frame: Randomization till VF progression, up to 36 months
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IOP change from baseline
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Randomization till VF progression, up to 36 months
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Best Correct Visual Acuity (BCVA)
Time Frame: Randomization till VF progression, up to 36 months
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BCVA change from baseline
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Randomization till VF progression, up to 36 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Luciano Quaranta, MD PhD, Università degli Studi di Brescia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRFMN-OG-7204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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