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

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

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

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.

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 compared to Pilocarpine and Brimonidine 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 - 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: Experimental PBOHB
Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.
Drug: Pilocarpine Hydrochloride
Apply in the fellow eye
Other Names:
  • Pil
Drug: Brimonidine Tartrate
Apply in the fellow eye
Other Names:
  • Brimonidine
Active Comparator: Pilocarpine 5 mgs
Pilocarpine was instilled in the other oye.
Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac
PBOHB to improve uncorrected near vision in healthy presbyopic patients
Other Names:
  • PBOHB
Active Comparator: Brimonidine 0.5 mgs
Brimonidine was instilled in the other eye.
Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac
PBOHB to improve uncorrected near vision in healthy presbyopic patients
Other Names:
  • PBOHB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of eyes improving 3 lines or more near visual acuity
Time Frame: 1 hour
Eyes instilled with PBOHB
1 hour
Eyes improving 3 lines or more near visual acuity
Time Frame: 1 hour
Eyes instilled with Pilocarpine
1 hour
Eyes improving 3 lines or more near VA
Time Frame: 1 hour
Eyes instilled with Brimonidine
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 10, 2021

Primary Completion (Anticipated)

August 30, 2021

Study Completion (Anticipated)

September 10, 2021

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 11, 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

  • PBOCP3

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

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.

Subscribe