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

NCT ID: NCT03611530

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-04
• Study Completion Date: 2022-04-29

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.

Conditions

Open Angle Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Coqun® ophthalmic solution

Intervention Type: DEVICE

Prostaglandin analogue (PGA) monotherapy + Coqun® ophthalmic solution

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.

Group Type: PLACEBO_COMPARATOR

Placebo ophthalmic solution

Intervention Type: OTHER

Prostaglandin analogue (PGA) monotherapy + Placebo ophthalmic solution

Interventions

Coqun® ophthalmic solution

Prostaglandin analogue (PGA) monotherapy + Coqun® ophthalmic solution

Intervention Type: DEVICE

Placebo ophthalmic solution

Prostaglandin analogue (PGA) monotherapy + Placebo ophthalmic solution

Intervention Type: OTHER

Other Intervention Names

Prostaglandin analogue (PGA) monotherapy; Prostaglandin analogue (PGA) monotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luciano Quaranta, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Locations

Università degli Studi di Brescia

Brescia, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 31301054 (View on PubMed)

Other Identifiers

IRFMN-OG-7204

Identifier Type: -

Identifier Source: org_study_id