Back to resultsCompound to Control Presbyopia Symptoms
Primary Purpose
Presbyopia
Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
PBO to control presbyopia symptoms
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 Vision
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
PBO Investigational drug
Pilocarpine
Brimonidine
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
Jaeger notation near uncorrected visual acuity change
Number of lines improved 1 hour after drug instillation
Comparison of PBO compound Jaeger notation improvement vs Pilocarpine or Brimonidine alone
Number of lines improve comparing PBO compound vs Pilocarpine or Brimonidine
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05006898
Brief Title
Compound to Control Presbyopia Symptoms
Official Title
Synergistic Use of Pilocarpine-Brimonidine-Oxymetazoline to Control Presbyopia Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
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
Low dose compose to control presbyopia symptoms
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.
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
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
ParticipantCare 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
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PBO Investigational drug
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
Arm Type
Active Comparator
Arm Description
Pilocarpine was instilled in the other oye.
Arm Title
Brimonidine
Arm Type
Active Comparator
Arm Description
Brimonidine was instilled in the other eye.
Intervention Type
Combination Product
Intervention Name(s)
PBO to control presbyopia symptoms
Other Intervention Name(s)
Pilocarpine, Brimonidine, Oxymetazoline
Intervention Description
Low dose PBO to control presbyopia symptoms
Primary Outcome Measure Information:
Title
Jaeger notation near uncorrected visual acuity change
Description
Number of lines improved 1 hour after drug instillation
Time Frame
1 hour
Title
Comparison of PBO compound Jaeger notation improvement vs Pilocarpine or Brimonidine alone
Description
Number of lines improve comparing PBO compound vs Pilocarpine or 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesar Alejandro S Galeana
Organizational Affiliation
Optall Vision
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optall Vision
City
Mexico City
ZIP/Postal Code
01090
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Compound to Control Presbyopia Symptoms
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