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

Mario Negri Institute for Pharmacological Research

Status: Terminated

Conditions: Open Angle Glaucoma

Treatments: Device: Coqun® ophthalmic solution; Other: Placebo ophthalmic solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03611530

IRFMN-OG-7204

Details and patient eligibility

About

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)

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 40 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 2 patient groups, including a placebo group

CoQun®

Experimental group

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.

Treatment:

Device: Coqun® ophthalmic solution

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo ophthalmic solution