Status:
UNKNOWN
Mirtogenol and Bimatoprost on IOP in Hispanics With Open-Angle Glaucoma
Lead Sponsor:
University of Puerto Rico
Conditions:
Glaucoma
Eligibility:
All Genders
21+ years
Phase:
NA
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...
Detailed Description
METHODOLOGY AND STUDY DESIGN A prospective, parallel-group, double-blind, randomized placebo-controlled clinical trial will be conducted with an estimated 72 primary open-angle glaucoma patients. A do...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04380025
Start Date
May 15 2020
End Date
May 15 2021
Last Update
May 8 2020
Active Locations (1)
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1
University of Puerto Rico, Medical Sciences Campus
San Juan, PR, Puerto Rico, 00936-5067