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

Sponsor
Optall Vision (Other)
Overall Status
Recruiting
CT.gov ID
NCT05001243
Collaborator
(none)
11
Enrollment
1
Location
3
Arms
1
Anticipated Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac
  • Drug: Pilocarpine Hydrochloride
  • Drug: Brimonidine Tartrate
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single Group Assignment To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound compared to Brimonidine and Pilocarpine to improve near uncorrected vision in healthy presbyopic patientsSingle Group Assignment To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound compared to Brimonidine and Pilocarpine to improve near uncorrected vision in healthy presbyopic patients
Masking:
Double (Participant, Care Provider)
Masking Description:
While in office the care provider took a number out of a closed container. Number 1 was designated for the Brimonidine, Number 2 was designated for the PBOHB compound, Number 3 was designated for de Pilocarpine compound
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 10, 2021
Anticipated Primary Completion Date :
Aug 30, 2021
Anticipated Study Completion Date :
Sep 10, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of eyes improving 3 lines or more near visual acuity [1 hour]

      Eyes instilled with PBOHB

    2. Eyes improving 3 lines or more near visual acuity [1 hour]

      Eyes instilled with Pilocarpine

    3. Eyes improving 3 lines or more near VA [1 hour]

      Eyes instilled with Brimonidine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy

    • Presbyopic

    • 40 - 59 years

    Exclusion Criteria:

    • Diabetics

    • Previous eye surgery

    • Previous eye disease

    • 0.50 myopia

    • 1.5 hyperopia or astigmatism

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Optall Vision Mexico City Mexico 01090

    Sponsors and Collaborators

    • Optall Vision

    Investigators

    • Principal Investigator: Cesar Alejandro S Galeana, MD, Optall Vision

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cesar Alejandro Sanchez Galeana, Principal Investigator, Optall Vision
    ClinicalTrials.gov Identifier:
    NCT05001243
    Other Study ID Numbers:
    • PBOCP3
    First Posted:
    Aug 11, 2021
    Last Update Posted:
    Aug 19, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Presbyopia
    Bromfenac
    Brimonidine Tartrate
    Phenylephrine
    Oxymetazoline
    Hyaluronic Acid
    Pilocarpine

    Study Results

    No Results Posted as of Aug 19, 2021