Journal
ADVANCES IN THERAPY
Volume 36, Issue 9, Pages 2506-2514Publisher
SPRINGER
DOI: 10.1007/s12325-019-01023-3
Keywords
Coenzyme Q10; Open-angle glaucoma; Ophthalmology; Prostaglandin analogue; Randomized clinical trial; Vitamin E
Funding
- Visufarma (Rome, Italy)
Ask authors/readers for more resources
Introduction The CoQun (R) study is a multicenter, controlled trial aimed to evaluate the neuroprotective effects of Coqun (R), 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. Methods Randomized, parallel arm, multicenter, double-blind study. POAG patients with an IOP ranging from 17 to 21 mm 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 - 10 dB and VF Pattern Standard Deviation between 4 and 10 dB. Eligible patients will be randomized to receive CoQun (R) (Arm A) or placebo (Arm B), in addition to PGA monotherapy. Planned Outcomes 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.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available