Valuation of the Antioxidant and Neuroprotective Effects of CoQ10-MINIACTIVES® (COQUN® OS) in Patients Affected by Primary Open Angle Glaucoma

Not Applicable

• Conditions: Glaucoma, Open-Angle
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: CoQ10- MINIACTIVES

• Registration Number: NCT04038034
• Lead Sponsor: VISUfarma SpA

Brief Summary

This is a randomized, double blind study with competitive enrolment, aimed to enroll a total of 70 patients with a diagnosis of primary open angle glaucoma (POAG).

Patients, after signing the Informed Consent, will enter into a 1- week screening phase during which the baseline tests will be conducted.

Subjects will be randomized in a 1:1 ratio to the following groups:

* group A of 35 patients treated with pressure lowering drugs and placebo;

* group B of 35 patients with pressure lowering drugs and COQUN oral formulation 100 mg BID.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-30
• Study Start: 2019-09-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-24
• Last Update Posted: 2020-04-28
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Placebo	35 patients treated with pressure lowering drugs and placebo
group B	CoQ10- MINIACTIVES	35 patients with pressure lowering drugs and COQUN oral formulation 100 mg BID.

Primary Outcome Measures

Name	Time	Method
Pattern Electroretinogram Amplitude (PERG P50-N95 A)	between the baseline visit (V0) and the last study visit after 12 months of treatment (V3)	To evaluate the difference of mean changes of Pattern Electroretinogram Amplitude (PERG P50-N95 A) (μV) observed between the two study groups.

Secondary Outcome Measures

Name	Time	Method
Optical Coherence Tomography	between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)	To evaluate the changes from baseline to each study visit between the two study groups in Peripapillary retinal nerve fiber layer (RNFL) thickness, macular RNFL, macular ganglion cell layer (GCL), macular inner plexiform layer (IPL) assessed with natural pupils by the means of spectral domain Optical Coherence Tomography (OCT, Heidelberg Spectralis)
Visual Evoked Potentials Implicit Times (VEP P100 IT)	between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)	To evaluate the changes from baseline to each study visit between the two study groups in Visual Evoked Potentials Implicit Times (VEP P100 IT) in milliseconds (ms)
Visual field	from baseline to each study visit (V1, V2, V3)	To evaluate the changes from baseline to each study visit between the two study groups in Visual field (separately MD and PSD) evaluated by Humphrey field analyzer (HFA) Sita Standard 30-2
Visual Evoked Potentials Amplitude (VEP N75-P100 A)	between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)	To evaluate the changes from baseline to each study visit between the two study groups in Visual Evoked Potentials Amplitude (VEP N75-P100 A) in microvolt (μV)
Pattern Electroretinogram Amplitude (PERG P50-N95 A)	between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)	To evaluate the difference of mean changes of Pattern Electroretinogram Amplitude (PERG P50-N95 A) (μV) observed between the two study groups.
Contrast sensitivity	between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)	To evaluate the changes from baseline to each study visit between the two study groups in Contrast sensitivity measured with Vistech tables (Vision Chart from CSO)
Pattern Electroretinogram Amplitude Implicit Times (PERG P50 IT)	between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)	To evaluate the changes from baseline to each study visit between the two study groups in Pattern Electroretinogram Amplitude Implicit Times (PERG P50 IT) in milliseconds (ms)

Trial Locations

Locations (2)

UO Oculistica - PO Cisanello; 🇮🇹 Pisa, PI, Italy

U.O. di Oculistica, Fondazione Policlinico Agostino A. Gemelli,; 🇮🇹 Rome, Italy