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.
| Original language | English |
|---|---|
| Journal | Advances in Therapy |
| DOIs | |
| Publication status | Published - Jan 1 2019 |
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Keywords
- Coenzyme Q10
- Open-angle glaucoma
- Ophthalmology
- Prostaglandin analogue
- Randomized clinical trial
- Vitamin E
ASJC Scopus subject areas
- Pharmacology (medical)
Cite this
Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Open-Angle Glaucoma Patients : A Study Protocol. / The CoQun® Study Group.
In: Advances in Therapy, 01.01.2019.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Open-Angle Glaucoma Patients
T2 - A Study Protocol
AU - The CoQun® Study Group
AU - Quaranta, Luciano
AU - Riva, Ivano
AU - Biagioli, Elena
AU - Rulli, Erica
AU - Rulli, Eliana
AU - Poli, Davide
AU - Legramandi, Lorenzo
AU - Fossarello, Maurizio
AU - Uva, Maurizio
AU - Carmassi, Luciana
AU - Gandolfi, Stefano
AU - Rossi, Gemma C.
AU - Fontana, Luigi
AU - Rolle, Teresa
AU - Tognetto, Daniele
AU - Mastropasqua, Leonardo
AU - Campos, Emilio
AU - Nucci, Carlo
AU - Scuderi, Gianluca
AU - Marchini, Giorgio
PY - 2019/1/1
Y1 - 2019/1/1
N2 - 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.
AB - 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.
KW - Coenzyme Q10
KW - Open-angle glaucoma
KW - Ophthalmology
KW - Prostaglandin analogue
KW - Randomized clinical trial
KW - Vitamin E
UR - http://www.scopus.com/inward/record.url?scp=85068866578&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85068866578&partnerID=8YFLogxK
U2 - 10.1007/s12325-019-01023-3
DO - 10.1007/s12325-019-01023-3
M3 - Article
AN - SCOPUS:85068866578
JO - Advances in Therapy
JF - Advances in Therapy
SN - 0741-238X
ER -