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Compound to Control Presbyopia Symptoms

Sponsor
Optall Vision (Other)
Overall Status
Completed
CT.gov ID
NCT05006898
Collaborator
(none)
11
Enrollment
1
Location
3
Arms
30
Actual Duration (Days)
11.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Low dose compose to control presbyopia symptoms

Condition or Disease Intervention/Treatment Phase
  • Combination Product: PBO to control presbyopia symptoms
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pilocarpine, brimonidine, oxymetazoline (PBO) compound was instilled in the non-dominant eye of presbyopic patients, while in the dominant eye pilocarpine or brimonidine were instilled.Pilocarpine, brimonidine, oxymetazoline (PBO) compound was instilled in the non-dominant eye of presbyopic patients, while in the dominant eye pilocarpine or brimonidine were instilled.
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 placebo; Number 2 was designated for the compound
Primary Purpose:
Treatment
Official Title:
Synergistic Use of Pilocarpine-Brimonidine-Oxymetazoline to Control Presbyopia Symptoms
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

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:
  • Pilocarpine
  • Brimonidine
  • 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:
  • Pilocarpine
  • Brimonidine
  • 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:
  • Pilocarpine
  • Brimonidine
  • Oxymetazoline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Jaeger notation near uncorrected visual acuity change [1 hour]

      Number of lines improved 1 hour after drug instillation

    2. Comparison of PBO compound Jaeger notation improvement vs Pilocarpine or Brimonidine alone [1 hour]

      Number of lines improve comparing PBO compound vs Pilocarpine or 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, 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:
    NCT05006898
    Other Study ID Numbers:
    • PBOPC01
    First Posted:
    Aug 16, 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
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Presbyopia
    Brimonidine Tartrate
    Oxymetazoline
    Pilocarpine

    Study Results

    No Results Posted as of Aug 19, 2021