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

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

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

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 Contact

Study Locations

  • Mexico
      • Mexico City, Mexico, 01090
        • Recruiting
        • 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

Yes

Genders Eligible for Study

All

Description

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 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PBOHB
Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac to evaluate safety and efficacy to improve uncorrected near vision in healthy presbyopic patients
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.
Other Names:
  • PBOHB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jaeger near uncorrected visual acuity improvement
Time Frame: 1 hour
Measure uncorrected near vision change after binocular instillation of PBOHB compound
1 hour

Collaborators and Investigators

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

Sponsor

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)

August 14, 2021

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

September 15, 2021

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (ACTUAL)

August 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 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

  • PBOPC02

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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