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

Primary Purpose

Glaucoma, Open-Angle

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

CoQ10- MINIACTIVES

Placebo

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Patient Informed consent form (ICF) signed
M & F Aged ≥ 40 and ≤ 80 years at the time of the signature of ICF
Patients with Primary Open Angle Glaucoma (POAG) stage early-moderate according to Hodapp-Parrish-Anderson criteria (MD less than -12 dB)
Patients must be diagnosed with POAG at least 1 year before the screening visit in this study.
Anamnesis with at least 1 value of Intraocular pressure (IOP) >21mmHg documented any time prior the initiation of the stable treatment with anti-hypertensive topical drugs.
Patients affected by POAG and under stable treatment with anti-hypertensive topical drugs in the previous 6 months prior to enrolment to maintain IOP ≤18 mmHg.
Corrected visual acuity (using ETDRS tables) ≥ 8/10
Transparent dioptric means to allow the examination of the OCT >25 μm.
Pachymetry values between 500 and 600 μm.
Patients have to show a stable visual field in the previous 6 months prior to enrolment (where by stable visual field it is intended that the patient must remain within the same stage of POAG severity (i.e. early or moderate) during the previous 6 months before the enrolment).
Willing to follow all study procedures, including attending all site visits, tests and examinations.
Women must agree to be using two forms of effective contraception, be post-menopausal from at least 12 months prior to trial entry, or surgically sterile.

Exclusion criteria:

Patients with a severe defect of POAG according to Hodapp-Parrish-Anderson criteria.
Previously diagnosed optic neuropathies.
Diabetic retinopathy or Hypertensive retinopathy.
Decompensated diabetes.
Not stabilized hypertension (SAP and/or DAP) despite under adequate pharmacological treatment.
Retinal pathologies including hereditary forms.
Neurological, neurodegenerative or cerebrovascular conditions.
No previous history or presence of any disease involving cornea or retina.
Patients with a significantly progressive opacity of lens in the previous 3 months prior to enrolment (where by significant progressive opacity of lens it is intended patients who have been diagnosed with cataracts of any aetiology and for whom surgery is being considered).
No surgical intervention for cataract in the previous 3 months prior to enrolment.
Eye inflammatory conditions (uveitis) diagnosed any time in the patient's history.
Treatment with topical or systemic neuroprotective agents different from CoQ10. These patients can be admitted in the study after at least a 1 month of wash-out period.
Treatment with warfarin.
Treatment with miotic drugs able to influence the visual field.
Treatment with systemic or topical steroids.
Refractive defects beyond the 5 spherical diopters, both positive and negative and over 3 cylindrical.
Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular, cancer or hematological disease.
Known drug and/or alcohol abuse.
Mental incapacity that precludes adequate understanding or cooperation.
Participation in another investigational study or blood donation within 3 months prior to ICF signature.

Sites / Locations

UO Oculistica - PO CisanelloRecruiting
U.O. di Oculistica, Fondazione Policlinico Agostino A. Gemelli,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

group A

group B

Arm Description

35 patients treated with pressure lowering drugs and placebo

35 patients with pressure lowering drugs and COQUN oral formulation 100 mg BID.

Outcomes

Primary Outcome Measures

Pattern Electroretinogram Amplitude (PERG P50-N95 A)

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

Pattern Electroretinogram Amplitude (PERG P50-N95 A)

To evaluate the difference of mean changes of Pattern Electroretinogram Amplitude (PERG P50-N95 A) (μV) observed between the two study groups.

Pattern Electroretinogram Amplitude Implicit Times (PERG P50 IT)

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)

Visual Evoked Potentials Implicit Times (VEP P100 IT)

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 Evoked Potentials Amplitude (VEP N75-P100 A)

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)

Visual field

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

Contrast sensitivity

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)

Optical Coherence Tomography

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)

Full Information

NCT ID

NCT04038034

First Posted

May 9, 2019

Last Updated

April 24, 2020

Sponsor

VISUfarma SpA

1. Study Identification

Unique Protocol Identification Number

NCT04038034

Brief Title

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

Official Title

Clinical Evaluation of the Antioxidant and Neuroprotective Effects of CoQ10-MINIACTIVES® (COQUN® OS) 100 mg BID Oral Administration in Patients Affected by Primary Open Angle Glaucoma (POAG): a Randomized, Double Blind Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

August 30, 2021 (Anticipated)

Study Completion Date

August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VISUfarma SpA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group A

Arm Type

Placebo Comparator

Arm Description

35 patients treated with pressure lowering drugs and placebo

Arm Title

group B

Arm Type

Experimental

Arm Description

35 patients with pressure lowering drugs and COQUN oral formulation 100 mg BID.

Intervention Type

Dietary Supplement

Intervention Name(s)

CoQ10- MINIACTIVES

Intervention Description

COQUN oral formulation 100 mg BID

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Pattern Electroretinogram Amplitude (PERG P50-N95 A)

Description

To evaluate the difference of mean changes of Pattern Electroretinogram Amplitude (PERG P50-N95 A) (μV) observed between the two study groups.

Time Frame

between the baseline visit (V0) and the last study visit after 12 months of treatment (V3)

Secondary Outcome Measure Information:

Title

Pattern Electroretinogram Amplitude (PERG P50-N95 A)

Description

To evaluate the difference of mean changes of Pattern Electroretinogram Amplitude (PERG P50-N95 A) (μV) observed between the two study groups.

Time Frame

between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)

Title

Pattern Electroretinogram Amplitude Implicit Times (PERG P50 IT)

Description

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)

Time Frame

between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)

Title

Visual Evoked Potentials Implicit Times (VEP P100 IT)

Description

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)

Time Frame

between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)

Title

Visual Evoked Potentials Amplitude (VEP N75-P100 A)

Description

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)

Time Frame

between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)

Title

Visual field

Description

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

Time Frame

from baseline to each study visit (V1, V2, V3)

Title

Contrast sensitivity

Description

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)

Time Frame

between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)

Title

Optical Coherence Tomography

Description

Time Frame

between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Patient Informed consent form (ICF) signed M & F Aged ≥ 40 and ≤ 80 years at the time of the signature of ICF Patients with Primary Open Angle Glaucoma (POAG) stage early-moderate according to Hodapp-Parrish-Anderson criteria (MD less than -12 dB) Patients must be diagnosed with POAG at least 1 year before the screening visit in this study. Anamnesis with at least 1 value of Intraocular pressure (IOP) >21mmHg documented any time prior the initiation of the stable treatment with anti-hypertensive topical drugs. Patients affected by POAG and under stable treatment with anti-hypertensive topical drugs in the previous 6 months prior to enrolment to maintain IOP ≤18 mmHg. Corrected visual acuity (using ETDRS tables) ≥ 8/10 Transparent dioptric means to allow the examination of the OCT >25 μm. Pachymetry values between 500 and 600 μm. Patients have to show a stable visual field in the previous 6 months prior to enrolment (where by stable visual field it is intended that the patient must remain within the same stage of POAG severity (i.e. early or moderate) during the previous 6 months before the enrolment). Willing to follow all study procedures, including attending all site visits, tests and examinations. Women must agree to be using two forms of effective contraception, be post-menopausal from at least 12 months prior to trial entry, or surgically sterile. Exclusion criteria: Patients with a severe defect of POAG according to Hodapp-Parrish-Anderson criteria. Previously diagnosed optic neuropathies. Diabetic retinopathy or Hypertensive retinopathy. Decompensated diabetes. Not stabilized hypertension (SAP and/or DAP) despite under adequate pharmacological treatment. Retinal pathologies including hereditary forms. Neurological, neurodegenerative or cerebrovascular conditions. No previous history or presence of any disease involving cornea or retina. Patients with a significantly progressive opacity of lens in the previous 3 months prior to enrolment (where by significant progressive opacity of lens it is intended patients who have been diagnosed with cataracts of any aetiology and for whom surgery is being considered). No surgical intervention for cataract in the previous 3 months prior to enrolment. Eye inflammatory conditions (uveitis) diagnosed any time in the patient's history. Treatment with topical or systemic neuroprotective agents different from CoQ10. These patients can be admitted in the study after at least a 1 month of wash-out period. Treatment with warfarin. Treatment with miotic drugs able to influence the visual field. Treatment with systemic or topical steroids. Refractive defects beyond the 5 spherical diopters, both positive and negative and over 3 cylindrical. Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular, cancer or hematological disease. Known drug and/or alcohol abuse. Mental incapacity that precludes adequate understanding or cooperation. Participation in another investigational study or blood donation within 3 months prior to ICF signature.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stanislao Rizzo

Phone

+39 06 301 54 929

stanislao.rizzo@policlinicogemelli.it

Facility Information:

Facility Name

UO Oculistica - PO Cisanello

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michele Figus, MD

Facility Name

U.O. di Oculistica, Fondazione Policlinico Agostino A. Gemelli,

City

Rome

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stanislao Rizzo, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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