Back to resultsComparison of a Compound With Pilocarpine and Brimonidine to Improve Near Vision in Healthy Presbyopic Patients (PBOHB)
Primary Purpose
Presbyopia
Status
Unknown status
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac
Pilocarpine Hydrochloride
Brimonidine Tartrate
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
- Healthy
- Presbyopic
- 40 - 59 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 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Experimental PBOHB
Pilocarpine 5 mgs
Brimonidine 0.5 mgs
Arm Description
Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.
Pilocarpine was instilled in the other oye.
Brimonidine was instilled in the other eye.
Outcomes
Primary Outcome Measures
Number of eyes improving 3 lines or more near visual acuity
Eyes instilled with PBOHB
Eyes improving 3 lines or more near visual acuity
Eyes instilled with Pilocarpine
Eyes improving 3 lines or more near VA
Eyes instilled with Brimonidine
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05001243
Brief Title
Comparison of a Compound With Pilocarpine and Brimonidine to Improve Near Vision in Healthy Presbyopic Patients
Acronym
PBOHB
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
September 10, 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
Data Monitoring Committee
Yes
5. 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.
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.
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
Parallel Assignment
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 patients
Masking
ParticipantCare 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
Allocation
Randomized
Enrollment
11 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental PBOHB
Arm Type
Experimental
Arm Description
Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.
Arm Title
Pilocarpine 5 mgs
Arm Type
Active Comparator
Arm Description
Pilocarpine was instilled in the other oye.
Arm Title
Brimonidine 0.5 mgs
Arm Type
Active Comparator
Arm Description
Brimonidine was instilled in the other eye.
Intervention Type
Drug
Intervention Name(s)
Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac
Other Intervention Name(s)
PBOHB
Intervention Description
PBOHB to improve uncorrected near vision in healthy presbyopic patients
Intervention Type
Drug
Intervention Name(s)
Pilocarpine Hydrochloride
Other Intervention Name(s)
Pil
Intervention Description
Apply in the fellow eye
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate
Other Intervention Name(s)
Brimonidine
Intervention Description
Apply in the fellow eye
Primary Outcome Measure Information:
Title
Number of eyes improving 3 lines or more near visual acuity
Description
Eyes instilled with PBOHB
Time Frame
1 hour
Title
Eyes improving 3 lines or more near visual acuity
Description
Eyes instilled with Pilocarpine
Time Frame
1 hour
Title
Eyes improving 3 lines or more near VA
Description
Eyes instilled with Brimonidine
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 - 59 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 S Perez
Phone
5591990342
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
Comparison of a Compound With Pilocarpine and Brimonidine to Improve Near Vision in Healthy Presbyopic Patients
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