Clinical trial NCT03611530: CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma
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
Overall status: TERMINATED
Phase: NA
Conditions: Open Angle Glaucoma
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 111
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Time to Progression (TTP)
timeFrame: Randomization till VF progression, up to 36 months
Secondary outcomes:
measure: Velocity of Visual Field (VF) loss
timeFrame: Randomization till VF progression, up to 36 months
measure: Retinal Nerve Fiber Layer (RNFL) thickness
timeFrame: Randomization till VF progression, up to 36 months
measure: Intraocular pressure (IOP)
timeFrame: Randomization till VF progression, up to 36 months
measure: Best Correct Visual Acuity (BCVA)
timeFrame: Randomization till VF progression, up to 36 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Università degli Studi di Brescia
Study officials:
affiliation: Università degli Studi di Brescia
name: Luciano Quaranta, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.