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NCT05006898 Clinical Trial

Compound to Control Presbyopia Symptoms

Presbyopia Clinical Trial

Official title:
Synergistic Use of Pilocarpine-Brimonidine-Oxymetazoline to Control Presbyopia Symptoms

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05006898
Other study ID # PBOPC01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 1, 2020
Est. completion date July 1, 2020

Study information
Verified date August 2021
Source Optall Vision
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Low dose compose to control presbyopia symptoms

Description:

A los dose compound including pilocarpine, brimonidine and oxymetazoline was use to control presbyopia symptoms compared to pilocarpine and brimonidine in low doses.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date July 1, 2020
Est. primary completion date July 1, 2020
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

Combination Product:
• PBO to control presbyopia symptoms
Low dose PBO to control presbyopia symptoms

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 notation near uncorrected visual acuity change Number of lines improved 1 hour after drug instillation 1 hour
Primary Comparison of PBO compound Jaeger notation improvement vs Pilocarpine or Brimonidine alone Number of lines improve comparing PBO compound vs Pilocarpine or Brimonidine 1 hour
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