- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04038034
Valuation of the Antioxidant and Neuroprotective Effects of CoQ10-MINIACTIVES® (COQUN® OS) in Patients Affected by Primary Open Angle Glaucoma
April 24, 2020 updated by: VISUfarma SpA
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stanislao Rizzo
- Phone Number: +39 06 301 54 929
- Email: stanislao.rizzo@policlinicogemelli.it
Study Locations
-
-
-
Rome, Italy
- Recruiting
- U.O. di Oculistica, Fondazione Policlinico Agostino A. Gemelli,
-
Contact:
- Stanislao Rizzo, MD
-
-
PI
-
Pisa, PI, Italy, 56124
- Recruiting
- UO Oculistica - PO Cisanello
-
Contact:
- Michele Figus, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: group A
35 patients treated with pressure lowering drugs and placebo
|
Placebo
|
Experimental: group B
35 patients with pressure lowering drugs and COQUN oral formulation 100 mg BID.
|
COQUN oral formulation 100 mg BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pattern Electroretinogram Amplitude (PERG P50-N95 A)
Time Frame: 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.
|
between the baseline visit (V0) and the last study visit after 12 months of treatment (V3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pattern Electroretinogram Amplitude (PERG P50-N95 A)
Time Frame: 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.
|
between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)
|
Pattern Electroretinogram Amplitude Implicit Times (PERG P50 IT)
Time Frame: 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)
|
between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)
|
Visual Evoked Potentials Implicit Times (VEP P100 IT)
Time Frame: 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)
|
between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)
|
Visual Evoked Potentials Amplitude (VEP N75-P100 A)
Time Frame: 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)
|
between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)
|
Visual field
Time Frame: 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
|
from baseline to each study visit (V1, V2, V3)
|
Contrast sensitivity
Time Frame: 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)
|
between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)
|
Optical Coherence Tomography
Time Frame: 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)
|
between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Anticipated)
August 30, 2021
Study Completion (Anticipated)
August 30, 2021
Study Registration Dates
First Submitted
May 9, 2019
First Submitted That Met QC Criteria
July 26, 2019
First Posted (Actual)
July 30, 2019
Study Record Updates
Last Update Posted (Actual)
April 28, 2020
Last Update Submitted That Met QC Criteria
April 24, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VF-GLAU-CoQ10/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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