Compound to Control Presbyopia Symptoms

August 14, 2021 updated by: Cesar Alejandro Sanchez Galeana, Optall Vision

Synergistic Use of Pilocarpine-Brimonidine-Oxymetazoline to Control Presbyopia Symptoms

Low dose compose to control presbyopia symptoms

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 01090
        • Optall Vision

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PBO Investigational drug
Pilocarpine, brimonidine, oxymetazoline combined with hyaluronic acid and bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.
Combination product: PBO to control presbyopia symptoms
Low dose PBO to control presbyopia symptoms
Other Names:
  • Brimonidine
  • Pilocarpine
  • Oxymetazoline
Active Comparator: Pilocarpine
Pilocarpine was instilled in the other oye.
Combination product: PBO to control presbyopia symptoms
Low dose PBO to control presbyopia symptoms
Other Names:
  • Brimonidine
  • Pilocarpine
  • Oxymetazoline
Active Comparator: Brimonidine
Brimonidine was instilled in the other eye.
Combination product: PBO to control presbyopia symptoms
Low dose PBO to control presbyopia symptoms
Other Names:
  • Brimonidine
  • Pilocarpine
  • Oxymetazoline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jaeger notation near uncorrected visual acuity change
Time Frame: 1 hour
Number of lines improved 1 hour after drug instillation
1 hour
Comparison of PBO compound Jaeger notation improvement vs Pilocarpine or Brimonidine alone
Time Frame: 1 hour
Number of lines improve comparing PBO compound vs Pilocarpine or Brimonidine
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optall Vision

Investigators

  • Principal Investigator: Cesar Alejandro S Galeana, Optall Vision

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 14, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBOPC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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