Glaucoma, Open-AngleNCT04038034
Valuation of the Antioxidant and Neuroprotective Effects of CoQ10-MINIACTIVES® (COQUN® OS) in Patients Affected by Primary Open Angle Glaucoma
A study testing CoQ10- MINIACTIVES in people with Glaucoma, Open-Angle, run by VISUfarma SpA at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- CoQ10- MINIACTIVES
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2019to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
UO Oculistica - PO Cisanello
Pisa, PI, 56124
Michele Figus, MD
- Recruiting
U.O. di Oculistica, Fondazione Policlinico Agostino A. Gemelli,
Rome
Stanislao Rizzo, MD
About this study
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
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.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- CoQ10- MINIACTIVES, Placebo
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoQ10- MINIACTIVESDietary supplement
COQUN oral formulation 100 mg BID
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| group A | Placebo comparator | 35 patients treated with pressure lowering drugs and placebo Receives: Dietary Supplement: Placebo |
| group B | Experimental | 35 patients with pressure lowering drugs and COQUN oral formulation 100 mg BID. Receives: Dietary Supplement: CoQ10- MINIACTIVES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between the baseline visit (V0) and the last study visit after 12 months of treatment (V3)
Secondary outcomes (7)
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.
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)
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
Measured: from baseline to each study visit (V1, V2, V3)
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)
Measured: 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
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)
Measured: between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Sep 2019
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VISUfarma SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038034
- Sponsor's protocol ID
- VF-GLAU-CoQ10/2019
- Status last verified
- Apr 2020
- First submitted
- 9 May 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04038034
- Acronym / sponsor ID
- VF-GLAU-CoQ10/2019
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- VISUfarma SpAIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Placebo comparator | Dietary Supplement: Placebo35 patients treated with pressure lowering drugs and placebo |
| group B | Experimental | Dietary Supplement: CoQ10- MINIACTIVES35 patients with pressure lowering drugs and COQUN oral formulation 100 mg BID. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoQ10- MINIACTIVESCOQUN oral formulation 100 mg BID | Dietary supplement | group B |
| PlaceboPlacebo | Dietary supplement | group A |
Primary outcome
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.
7 secondary outcomes
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)
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)
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)
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)
Visual field
Time frame: 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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoQ10- MINIACTIVES in people with Glaucoma, Open-Angle, run by VISUfarma SpA at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stanislao Rizzo (+39 06 301 54 929, stanislao.rizzo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.