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

NCT03611530 | Terminated

• 1 other identifier: IRFMN-OG-7204
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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)

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Velocity of Visual Field (VF) loss

  Randomization till VF progression, up to 36 months

• Retinal Nerve Fiber Layer (RNFL) thickness

  Randomization till VF progression, up to 36 months

• Intraocular pressure (IOP)

  Randomization till VF progression, up to 36 months

• Best Correct Visual Acuity (BCVA)

  Randomization till VF progression, up to 36 months

Study Arms (2)

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.

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.

Other: Placebo ophthalmic solution

Interventions

Coqun® ophthalmic solution DEVICE

Prostaglandin analogue (PGA) monotherapy + Coqun® ophthalmic solution

Also known as: Prostaglandin analogue (PGA) monotherapy

CoQun®

Placebo ophthalmic solution OTHER

Prostaglandin analogue (PGA) monotherapy + Placebo ophthalmic solution

Also known as: Prostaglandin analogue (PGA) monotherapy

Placebo

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

Università degli Studi di Brescia

Brescia, Italy

Location

Related Publications (1)

• 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.

  PMID: 31301054 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Prostaglandins, Synthetic; Prostaglandins A

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Luciano Quaranta, MD PhD

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: August 2, 2018
• Study Start: September 4, 2017
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)