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: Terminated
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: Device: Coqun® ophthalmic solution; Other: Placebo ophthalmic solution

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: Interventional
• Enrollment (Actual): 111
• 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

• Italy
  • Brescia, Italy
    • Università degli Studi di Brescia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. 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.
3. 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.
4. Age >40 years
5. Provision of informed consent prior to any study specific procedures

Exclusion Criteria:

1. Secondary glaucoma (exofoliative glaucoma, pigmentary glaucoma, neovascular glaucoma).
2. Abnormalities of the anterior segment of the eye that could affect IOP assessment.
3. Cornea abnormalities with entities that could affect IOP evaluation.
4. Other conditions different from glaucoma that could cause VF abnormalities (degenerative myopia, diabetic retinopathy, maculopathy, other optic nerve abnormalities that could mimic glaucoma damage).
5. BCVA) < 0.5 Snellen decimal fraction
6. Any previous ocular surgery except for uncomplicated cataract extraction and YAG laser capsulotomy, laser glaucoma surgeries (argon laser trabeculoplasty and/or selective laser trabeculoplasty).
7. Pregnancy or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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.	Device: Coqun® ophthalmic solution; Prostaglandin analogue (PGA) monotherapy + Coqun® ophthalmic solution; Other Names: Prostaglandin analogue (PGA) monotherapy
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.	Other: Placebo ophthalmic solution; Prostaglandin analogue (PGA) monotherapy + Placebo ophthalmic solution; Other Names: Prostaglandin analogue (PGA) monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Randomization till VF progression, up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Randomization till VF progression, up to 36 months
Retinal Nerve Fiber Layer (RNFL) thickness	RNFL thickness by the means of OCT: change from baseline	Randomization till VF progression, up to 36 months
Intraocular pressure (IOP)	IOP change from baseline	Randomization till VF progression, up to 36 months
Best Correct Visual Acuity (BCVA)	BCVA change from baseline	Randomization till VF progression, up to 36 months

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research
• Investigators: Principal Investigator: Luciano Quaranta, MD PhD, Università degli Studi di Brescia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2017
• Primary Completion (Actual): April 29, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: IRFMN-OG-7204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No