Mirtogenol and Bimatoprost on IOP in Hispanics With Open-Angle Glaucoma

NCT04380025 | Unknown

• 1 other identifier: A4570119
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, parallel-group, double-blind, randomized placebo-controlled clinical study will be conducted with an estimated 72 participants. The objective of this study is to determine if Mirtogenol has an additive effect on the reduction of intraocular pressure when combined with bimatoprost in the Hispanic population with primary open angle glaucoma. Baseline clinical data will be collected for each participant and they will be randomized 1:1 to a treatment group (bimatoprost 0.01% and Mirtogenol) or control group (bimatoprost 0.01% and placebo). Efficacy and safety of Mirtogenol will be measured during the 24 week study. Participants will be evaluated in five visits: screening and baseline, week 4, week 8, week 12 and week 24. The tests that will be performed include visual acuity, visual field evaluation, applanation tonometry, optical coherence tomography (OCT), and pachymetry. Side effects or adverse effects will be reported and evaluated by the ophthalmologist at each visit to access the safety of Mirtogenol. The primary efficacy endpoint of intraocular pressure (IOP) will be compared using a t-test and will have an 80% probability to detect a difference between treatments at a 0.05 significance level.

Conditions

Glaucoma

Keywords

bimatoprost; hispanic; Mirtogenol; bilberry; Pycnogenol

Outcome Measures

Primary Outcomes (1)

• Change in intraocular pressure (IOP)

  intraocular pressure (IOP) will be compared using a t-test and will have an 80% probability to detect a difference between treatments at a 0.05 significance level.

  Participants will be evaluated in five visits: screening and baseline, week 4, week 8, week 12 and week 24.

Secondary Outcomes (1)

• Change in the Tolerance of the experimental supplement

  24 weeks

Study Arms (2)

Mirtogenol

EXPERIMENTAL

In addition of conventional treatment with glaucoma ophtalmic drop medication (bimatoprost) the experimental group will also take Mirtogenol. Mirtogenol is a dietary supplement composed of bilberry and pycnogenol which are botanical compounds with antioxidant properties. The active components of bilberry are flavonoid anthocyanosides (anthocyanins). Anthocyanosides are the only flavonoids able to reach the eye as a target organ in experimental animals. Unchanged anthocyanosides demonstrated after oral administration that it is absorbed and distributed into ocular tissues, showing its ability to pass through the blood-aqueous and blood retinal barriers.6

Dietary Supplement: Experimental: Oral Mirtogenol

Lactose based Placebo

PLACEBO COMPARATOR

In addition of conventional treatment with glaucoma ophtalmic drop medication (bimatoprost) this control group will also take an identical placebo. This placebo is a inactive lactose based product of the same color and size capsule.

Dietary Supplement: Placebo of oral Dietary supplement

Interventions

Experimental: Oral Mirtogenol DIETARY_SUPPLEMENT

The experimental arm is Oral Mirtogenol dietary supplement, one capsule daily in addition to bimatoprost ophthalmic drops with primary open angle glaucoma

Also known as: Bilberry with pycnogenol

Mirtogenol

Placebo of oral Dietary supplement DIETARY_SUPPLEMENT

This is the oral placebo of the supplement (control) un daily capsule in addition to the bimatoprost ophtalmic drops

Also known as: lactose and food grade dyes

Lactose based Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with primary open-angle glaucoma (POAG)
• over 21 yrs
• Self identified as hispanic
• Current glaucoma treatment regimen of monotherapy with bimatoprost 0.01% applie into affected eye(s) once daily and with stable IOP less or equal to 21 mmHG

You may not qualify if:

• Less than 21 year old
• Pregnant women (self-reported) or those who are planning to become pregnant in the next six (6) months (There is insufficient reliable information available about the safety of Mirtogenol® when used in medicinal amounts during pregnancy and lactation)
• Women who are breastfeeding (There is insufficient reliable information available about the safety of Mirtogenol® when used in medicinal amounts during pregnancy and lactation)
• Individuals with cardiovascular diseases that have required medical intervention in the past three (3) months
• Patients that required any kind of surgery, radiotherapy or chemotherapy in the past three (3) months
• Patients with advanced glaucoma with a cup to disk ratio \> 0.9, previous glaucoma surgeries or other abnormalities of the eye that affect the visual pathway

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

University of Puerto Rico, Medical Sciences Campus

San Juan, PR, 00936-5067, Puerto Rico

Location

Related Publications (6)

• Steigerwalt RD Jr, Belcaro G, Morazzoni P, Bombardelli E, Burki C, Schonlau F. Mirtogenol potentiates latanoprost in lowering intraocular pressure and improves ocular blood flow in asymptomatic subjects. Clin Ophthalmol. 2010 May 14;4:471-6. doi: 10.2147/opth.s9899.

  PMID: 20505841 BACKGROUND

• Gizzi C, Torino-Rodriguez P, Belcaro G, Hu S, Hosoi M, Feragalli B. Mirtogenol(R) supplementation in association with dorzolamide-timolol or latanoprost improves the retinal microcirculation in asymptomatic patients with increased ocular pressure. Eur Rev Med Pharmacol Sci. 2017 Oct;21(20):4720-4725.

  PMID: 29131240 BACKGROUND

• Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.

  PMID: 16488940 RESULT

• Distelhorst JS, Hughes GM. Open-angle glaucoma. Am Fam Physician. 2003 May 1;67(9):1937-44.

  PMID: 12751655 RESULT

• Munemasa Y, Kitaoka Y. Molecular mechanisms of retinal ganglion cell degeneration in glaucoma and future prospects for cell body and axonal protection. Front Cell Neurosci. 2013 Jan 9;6:60. doi: 10.3389/fncel.2012.00060. eCollection 2012.

  PMID: 23316132 RESULT

• Steigerwalt RD, Gianni B, Paolo M, Bombardelli E, Burki C, Schonlau F. Effects of Mirtogenol on ocular blood flow and intraocular hypertension in asymptomatic subjects. Mol Vis. 2008 Jul 10;14:1288-92.

  PMID: 18618008 RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

Vaccinium myrtillus extract; pycnogenols; Lactose

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Jorge R Miranda, Pham.D.

  School of Pharmacy, University of Puerto Rico, Medical Sciences Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge R Miranda, Pharm.D.

CONTACT

7876460720; jorge.miranda2@upr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This is a double blind study. The participant and the medical care provider will not know the identity of the placebo or study product.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, parallel-group, double-blind, randomized placebo-controlled clinical trial will be conducted with an estimated 72 primary open-angle glaucoma patients. A double blind RCT was chosen to minimize bias and yield similar groups with the same prognostic at baseline to avoid compromising the validity of the study results. The primary efficacy endpoint of the study will be IOP and the secondary endpoint will be the safety analysis.

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: May 8, 2020
• Study Start: May 15, 2020
• Primary Completion: March 15, 2021
• Study Completion: May 15, 2021
• Last Updated: May 8, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)