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

Primary Purpose

Presbyopia

Status
Unknown status
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound
Sponsored by
Optall Vision
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy
  • Presbyopic
  • 40 - 60 years

Exclusion Criteria:

  • Diabetics
  • Previous eye surgery
  • Previous eye disease
  • > 0.50 myopia
  • > 1.5 hyperopia or astigmatism

Sites / Locations

  • Optall VisionRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PBOHB

Arm Description

Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac to evaluate safety and efficacy to improve uncorrected near vision in healthy presbyopic patients

Outcomes

Primary Outcome Measures

Jaeger near uncorrected visual acuity improvement
Measure uncorrected near vision change after binocular instillation of PBOHB compound

Secondary Outcome Measures

Full Information

First Posted
August 4, 2021
Last Updated
August 14, 2021
Sponsor
Optall Vision
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1. Study Identification

Unique Protocol Identification Number
NCT05006911
Brief Title
Pilocarpine, Brimonidine, Oxymetazoline (PBO) Compound to Control Presbyopia Symptoms
Acronym
PBO
Official Title
Pilocarpine, Brimonidine, Oxymetazoline Ophthalmic Compound Safety and Efficacy in Patients With Presbyopia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 14, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Optall Vision

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound to improve near uncorrected vision in healthy presbyopic patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PBOHB
Arm Type
Experimental
Arm Description
Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac to evaluate safety and efficacy to improve uncorrected near vision in healthy presbyopic patients
Intervention Type
Drug
Intervention Name(s)
Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound
Other Intervention Name(s)
PBOHB
Intervention Description
To determine the safety and efficacy of a PBOHB compound in near vision of presbyopic patients.
Primary Outcome Measure Information:
Title
Jaeger near uncorrected visual acuity improvement
Description
Measure uncorrected near vision change after binocular instillation of PBOHB compound
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Presbyopic 40 - 60 years Exclusion Criteria: Diabetics Previous eye surgery Previous eye disease > 0.50 myopia > 1.5 hyperopia or astigmatism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cesar Alejandro S Galeana, MD
Phone
5541851511
Email
optallvision@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rosario Perez
Phone
559199042
Email
optallvision@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesar Alejandro S Galeana, MD
Organizational Affiliation
Optall Vision
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optall Vision
City
Mexico City
ZIP/Postal Code
01090
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar Alejandro S Galeana, MD
Phone
5541851511
Email
optallvision@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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