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NCT05001243 Clinical Trial

Comparison of a Compound With Pilocarpine and Brimonidine to Improve Near Vision in Healthy Presbyopic Patients

Presbyopia Clinical Trial

— PBOHB  

Official title:
Comparison of Pilocarpine, Brimonidine, Oxymetazoline, Hialuronic Acid, Bromfenac Ophthalmic Compound With Pilocarpine and Brimonidine to Improve Uncorrected Visual Acuity in Healthy Presbyopic Individuals

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05001243
Other study ID # PBOCP3
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 10, 2021
Est. completion date September 10, 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 compared to Pilocarpine and Brimonidine 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 compared to Pilocarpine and Brimonidine one hour after binocular instillation.

Recruitment information / eligibility
Status Recruiting
Enrollment 11
Est. completion date September 10, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Healthy - Presbyopic - 40 - 59 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:
• Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac
PBOHB to improve uncorrected near vision in healthy presbyopic patients
• Pilocarpine Hydrochloride
Apply in the fellow eye
• Brimonidine Tartrate
Apply in the fellow eye

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 Number of eyes improving 3 lines or more near visual acuity Eyes instilled with PBOHB 1 hour
Primary Eyes improving 3 lines or more near visual acuity Eyes instilled with Pilocarpine 1 hour
Primary Eyes improving 3 lines or more near VA Eyes instilled with Brimonidine 1 hour
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