NCT03611530

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Coqun® ophthalmic solution	Prostaglandin analogue (PGA) monotherapy + Coqun® ophthalmic solution
OTHER	Placebo ophthalmic solution	Prostaglandin analogue (PGA) monotherapy + Placebo ophthalmic solution

Timeline

• Start date: 2017-09-04
• Primary completion: 2022-04-29
• Completion: 2022-04-29
• First posted: 2018-08-02
• Last updated: 2024-03-13

Locations

1 site across 1 country: Italy