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

NCT04380025 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-05-08

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Experimental: Oral Mirtogenol

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

DIETARY_SUPPLEMENT

Placebo of oral Dietary supplement

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

Sponsors & Collaborators

  • University of Puerto Rico

    lead OTHER

Principal Investigators

  • Jorge R Miranda, Pham.D. · School of Pharmacy, University of Puerto Rico, Medical Sciences Campus

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2021-03-15
Completion
2021-05-15

Countries

  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04380025 on ClinicalTrials.gov