Back to resultsEvaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control lenses
Test lenses
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
- Is at least 42 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Self reports having a full eye examination in the previous two years;
- Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
- Has refractive astigmatism no higher than -0.75DC;
Is presbyopic and requires a reading addition of at least +0.75D and no more than
+2.50D;
- Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)
Exclusion Criteria:
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
- Has known sensitivity to the diagnostic sodium fluorescein used in the study;
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Has undergone refractive error surgery or intraocular surgery.
Sites / Locations
- Coan EyeCare
- Kannarr Eye care
- Sacco Eye Group PLLC
- ProCare Vision Center
- Nittany Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Lens
Test Lens
Arm Description
All subjects will wear control lenses for two weeks and then will wear Test lenses for two weeks.
After wearing control lenses for two weeks, all subjects will wear test lenses for two weeks.
Outcomes
Primary Outcome Measures
Comfort on Insertion
Subjective ratings of comfort on insertion using a 0-10 scale, in 0.5 steps (0=- painful, 10- Can't feel the lenses).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04952701
Brief Title
Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design
Official Title
Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
January 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of the study was to adapt existing multifocal soft lens wearers to a CONTROL lens for 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.
Detailed Description
This was a prospective, crossover, bilateral daily wear, and subject masked dispensing study. The habitual contact lenses were not optimized. There was no randomization of the study lenses, participants wore the control lenses for the first wear period and the test for the second wear period. Participants wore each study lens for 3-7 days and then attend a prescription optimization visit. After this optimization visit, they wore each study lens for a 2-week period. During the 2-week wear period, participants recorded their subjective lens-wear experience remotely.
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
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Lens
Arm Type
Active Comparator
Arm Description
All subjects will wear control lenses for two weeks and then will wear Test lenses for two weeks.
Arm Title
Test Lens
Arm Type
Experimental
Arm Description
After wearing control lenses for two weeks, all subjects will wear test lenses for two weeks.
Intervention Type
Device
Intervention Name(s)
Control lenses
Intervention Description
Control Multifocal lenses
Intervention Type
Device
Intervention Name(s)
Test lenses
Intervention Description
Test Multifocal lenses
Primary Outcome Measure Information:
Title
Comfort on Insertion
Description
Subjective ratings of comfort on insertion using a 0-10 scale, in 0.5 steps (0=- painful, 10- Can't feel the lenses).
Time Frame
Day 1 after Lens Dispense Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Is at least 42 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Self reports having a full eye examination in the previous two years;
Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
Has refractive astigmatism no higher than -0.75DC;
Is presbyopic and requires a reading addition of at least +0.75D and no more than
+2.50D;
Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)
Exclusion Criteria:
Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
Has known sensitivity to the diagnostic sodium fluorescein used in the study;
Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
Has undergone refractive error surgery or intraocular surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones
Organizational Affiliation
University of Waterloo
Official's Role
Study Director
Facility Information:
Facility Name
Coan EyeCare
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Kannarr Eye care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Sacco Eye Group PLLC
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
ProCare Vision Center
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
Nittany Eye Associates
City
College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design
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