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Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Open-Angle Glaucoma Patients: A Study Protocol
- Publication Year :
- 2019
-
Abstract
- Introduction: 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. 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® (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. Trial Registration: ClinicalTrials.gov identifier, NCT03611530.
- Subjects :
- Male
030213 general clinical medicine
medicine.medical_specialty
Open angle glaucoma
medicine.drug_class
Ubiquinone
Glaucoma
Placebo
law.invention
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Randomized controlled trial
Double-Blind Method
law
Settore MED/30
Ophthalmology
medicine
Humans
Vitamin E
Pharmacology (medical)
Open-angle glaucoma
Intraocular Pressure
Aged
Coenzyme Q10
business.industry
Hazard ratio
General Medicine
Prostaglandin analogue
Randomized clinical trial
Middle Aged
medicine.disease
Clinical trial
chemistry
030220 oncology & carcinogenesis
Female
Ophthalmic Solutions
Visual Fields
business
Glaucoma, Open-Angle
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....124303a2b4101053bbd5c509b22ded73