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.

Evaluating the effects of an ophthalmic solution of coenzyme Q10 and vitamin E in open angle glaucoma patients: a study protocol / Quaranta L; Riva I; Biagioli E; rulli E; Poli D; Legramandi L; Fossarello M; Uva M; Carmassi L; Gandolfi S; Rossi GC; Fontana L; Rolle T; Tognetto D; Mastropasqua L; Campos E; Nucci C; Scuderi G; Marchini G. - In: ADVANCES IN THERAPY. - ISSN 0741-238X. - STAMPA. - 36:9(2019), pp. 2506-2514. [10.1007/s12325-019-01023-3]

Evaluating the effects of an ophthalmic solution of coenzyme Q10 and vitamin E in open angle glaucoma patients: a study protocol

Fontana L;Campos E;
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.
2019
Evaluating the effects of an ophthalmic solution of coenzyme Q10 and vitamin E in open angle glaucoma patients: a study protocol / Quaranta L; Riva I; Biagioli E; rulli E; Poli D; Legramandi L; Fossarello M; Uva M; Carmassi L; Gandolfi S; Rossi GC; Fontana L; Rolle T; Tognetto D; Mastropasqua L; Campos E; Nucci C; Scuderi G; Marchini G. - In: ADVANCES IN THERAPY. - ISSN 0741-238X. - STAMPA. - 36:9(2019), pp. 2506-2514. [10.1007/s12325-019-01023-3]
Quaranta L; Riva I; Biagioli E; rulli E; Poli D; Legramandi L; Fossarello M; Uva M; Carmassi L; Gandolfi S; Rossi GC; Fontana L; Rolle T; Tognetto D; Mastropasqua L; Campos E; Nucci C; Scuderi G; Marchini G
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/904280
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