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

Study Overview
=================
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.

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

Conditions
-----------------
Open Angle Glaucoma

Intervention / Treatment
-----------------
* Device: Coqun® ophthalmic solution
* Other: Placebo ophthalmic solution


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoQun®<br>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<br>* Prostaglandin analogue (PGA) monotherapy + Coqun® ophthalmic solution<br>* Other names: Prostaglandin analogue (PGA) monotherapy;|
| Placebo Comparator: Placebo<br>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<br>* Prostaglandin analogue (PGA) monotherapy + Placebo ophthalmic solution<br>* 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 |