Department of Surgical & Clinical, Diagnostic and Pediatric Sciences, Section of Ophthalmology, University of Pavia, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.
IRCCS - Fondazione Bietti, Rome, Italy.
Adv Ther. 2019 Sep;36(9):2506-2514. doi: 10.1007/s12325-019-01023-3. Epub 2019 Jul 12.
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.
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.
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.
ClinicalTrials.gov identifier, NCT03611530.
CoQun 研究是一项多中心、对照试验，旨在评估 CoQun（一种辅酶 Q10（CoQ10）和维生素 E（VitE）的眼科溶液）对原发性开角型青光眼（POAG）患者的神经保护作用。先前的临床前研究和小型非对照临床试验表明，CoQ10 和 VitE 在体外和体内均具有潜在的青光眼神经保护作用。
随机、平行臂、多中心、双盲研究。将接受前列腺素类似物（PGA）单药治疗的 IOP 范围在 17 至 21 mmHg 的 POAG 患者考虑入组本研究。纳入标准为视野（VF）平均偏差在-4 至-10 dB 之间，VF 模式标准差在 4 至 10 dB 之间。符合条件的患者将被随机分配接受 CoQun（A 组）或安慰剂（B 组），并联合 PGA 单药治疗。
主要结局为进展时间，定义为基线访视至确诊 VF 进展访视之间的时间。计划纳入 612 例患者，以检测危险比为 0.65，效力为 80%，α误差为 0.05（双侧）。为了研究效力计算，假设 10%的患者不可评估。这是第一项在随机、双盲和对照条件下研究 CoQ10 和 VitE 对 POAG 患者神经保护作用的研究。
ClinicalTrials.gov 标识符，NCT03611530。
