Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Open-Angle Glaucoma Patients: A Study Protocol.

Abstract

The CoQun® study is a multicenter, controlled trial aimed to evaluate the neuroprotective effects of Coqun®, an ophthalmic solution of Coenzyme q10 (CoQ10) and Vitamin E (VitE), in patients affected by primary open-angle glaucoma (POAG). Pre-clinical studies and small non-controlled clinical trials have previously shown a potential role of CoQ10 and VitE in glaucoma neuroprotection, both in vitro and in vivo. Randomized, parallel arm, multicenter, double-blind study. POAG patients with an IOP ranging from 17 to 21mm Hg on monotherapy with a prostaglandin analogue (PGA) will be considered for study enrollment. Inclusion criteria will be visual field (VF) mean deviation between -4 and -10dB and VF Pattern Standard Deviation between 4 and 10dB. Eligible patients will be randomized to receive CoQun® (Arm A) or placebo (Arm B), in addition to PGA monotherapy. Primary outcome will be time to progression, defined as the time between the baseline visit and the visit with confirmed VF progression. A total of 612 patients are planned to be enrolled, to detect a hazard ratio of 0.65, with a power of 80% and an alpha error of 0.05 (two-sided). For study power calculation, 10% non-evaluable patients are assumed. This is the first study investigating, in a randomized, double-blind and controlled fashion, the neuroprotective effects of CoQ10 and VitE in POAG patients. ClinicalTrials.gov identifier, NCT03611530.