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NCT05006911 Clinical Trial

Pilocarpine, Brimonidine, Oxymetazoline (PBO) Compound to Control Presbyopia Symptoms

Presbyopia Clinical Trial

— PBO  

Official title:
Pilocarpine, Brimonidine, Oxymetazoline Ophthalmic Compound Safety and Efficacy in Patients With Presbyopia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05006911
Other study ID # PBOPC02
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 14, 2021
Est. completion date September 15, 2021

Study information
Verified date August 2021
Source Optall Vision
Contact Cesar Alejandro S Galeana, MD
Phone 5541851511
Email optallvision@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound to improve uncorrected near vision in healthy presbyopic patients one hour after instillation.

Description:

To determine the safety and efficacy of a novel pharmacological compound of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) to improve uncorrected near vision in healthy presbyopic patients one hour after binocular instillation.

Recruitment information / eligibility
Status Recruiting
Enrollment 11
Est. completion date September 15, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Healthy - Presbyopic - 40 - 60 years Exclusion Criteria: - Diabetics - Previous eye surgery - Previous eye disease - > 0.50 myopia - > 1.5 hyperopia or astigmatism

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound
To determine the safety and efficacy of a PBOHB compound in near vision of presbyopic patients.

Locations
Country Name City State
Mexico Optall Vision Mexico City

Sponsors (1)
Lead Sponsor Collaborator
Optall Vision

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Jaeger near uncorrected visual acuity improvement Measure uncorrected near vision change after binocular instillation of PBOHB compound 1 hour
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