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CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma (CoQun)

Primary Purpose

Open Angle Glaucoma

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Coqun® ophthalmic solution

Placebo ophthalmic solution

About this trial

This is an interventional other trial for Open Angle Glaucoma

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Università degli Studi di BresciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CoQun®

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Retinal Nerve Fiber Layer (RNFL) thickness

RNFL thickness by the means of OCT: change from baseline

Intraocular pressure (IOP)

IOP change from baseline

Best Correct Visual Acuity (BCVA)

BCVA change from baseline

Full Information

NCT ID

NCT03611530

First Posted

September 4, 2017

Last Updated

September 28, 2018

Sponsor

Mario Negri Institute for Pharmacological Research

1. Study Identification

Unique Protocol Identification Number

NCT03611530

Brief Title

CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma

Acronym

CoQun

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 4, 2017 (Actual)

Primary Completion Date

February 28, 2021 (Anticipated)

Study Completion Date

February 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mario Negri Institute for Pharmacological Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open Angle Glaucoma

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double blind study

Allocation

Randomized

Enrollment

612 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CoQun®

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Coqun® ophthalmic solution

Other Intervention Name(s)

Prostaglandin analogue (PGA) monotherapy

Intervention Description

Prostaglandin analogue (PGA) monotherapy + Coqun® ophthalmic solution

Intervention Type

Other

Intervention Name(s)

Placebo ophthalmic solution

Other Intervention Name(s)

Prostaglandin analogue (PGA) monotherapy

Intervention Description

Prostaglandin analogue (PGA) monotherapy + Placebo ophthalmic solution

Primary Outcome Measure Information:

Title

Time to Progression (TTP)

Description

Time Frame

Randomization till VF progression, up to 36 months

Secondary Outcome Measure Information:

Title

Velocity of Visual Field (VF) loss

Description

VF loss as determined by Guided Progression Analysis software (version 5.1.1) will be assessed at the last VF examination.

Time Frame

Randomization till VF progression, up to 36 months

Title

Retinal Nerve Fiber Layer (RNFL) thickness

Description

RNFL thickness by the means of OCT: change from baseline

Time Frame

Randomization till VF progression, up to 36 months

Title

Intraocular pressure (IOP)

Description

IOP change from baseline

Time Frame

Randomization till VF progression, up to 36 months

Title

Best Correct Visual Acuity (BCVA)

Description

BCVA change from baseline

Time Frame

Randomization till VF progression, up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elena Biagioli, Pharm. D

Phone

0039 02 3901 4650

elena.biagioli@marionegri.it

First Name & Middle Initial & Last Name or Official Title & Degree

Erica Rulli

Phone

0039 02 3901 4684

erica.rulli@marionegri.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luciano Quaranta, MD PhD

Organizational Affiliation

Università degli Studi di Brescia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Università degli Studi di Brescia

City

Brescia

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luciano Quaranta, MD PhD

Phone

0039 0303995847

luciano.quaranta@unibs.it

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31301054

Citation

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.

Results Reference

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CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma

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