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

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1 Citation (Scopus)

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 languageEnglish
JournalAdvances in Therapy
DOIs
Publication statusPublished - Jan 1 2019

Fingerprint

coenzyme Q10
Ophthalmic Solutions
Open Angle Glaucoma
Vitamin E
Visual Fields
Synthetic Prostaglandins
Neuroprotective Agents
Double-Blind Method
Glaucoma
Multicenter Studies
Placebos

Keywords

  • Coenzyme Q10
  • Open-angle glaucoma
  • Ophthalmology
  • Prostaglandin analogue
  • Randomized clinical trial
  • Vitamin E

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

@article{4eff99e2b5974fa4981d854018679928,
title = "Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Open-Angle Glaucoma Patients: A Study Protocol",
abstract = "Introduction: The CoQun{\circledR} study is a multicenter, controlled trial aimed to evaluate the neuroprotective effects of Coqun{\circledR}, 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{\circledR} (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.",
keywords = "Coenzyme Q10, Open-angle glaucoma, Ophthalmology, Prostaglandin analogue, Randomized clinical trial, Vitamin E",
author = "{The CoQun{\circledR} Study Group} and Luciano Quaranta and Ivano Riva and Elena Biagioli and Erica Rulli and Eliana Rulli and Davide Poli and Lorenzo Legramandi and Maurizio Fossarello and Maurizio Uva and Luciana Carmassi and Stefano Gandolfi and Rossi, {Gemma C.} and Luigi Fontana and Teresa Rolle and Daniele Tognetto and Leonardo Mastropasqua and Emilio Campos and Carlo Nucci and Gianluca Scuderi and Giorgio Marchini",
year = "2019",
month = "1",
day = "1",
doi = "10.1007/s12325-019-01023-3",
language = "English",
journal = "Advances in Therapy",
issn = "0741-238X",
publisher = "Springer Healthcare",

}

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

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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 -