Back to resultsEvaluation of the Performance of Monthly Replacement Sphere Lens Designs in Habitual Soft Contact Lens Wearers
Primary Purpose
Myopia, Hyperopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lens A (comfilcon A lens)
Lens B (lehfilcon A lens)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Self-reports having a full eye examination in the previous two years;
- Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smart- phone;
- Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
- Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
- Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens brand is restricted such that no more than one third are to be the Biofinity brand (or their equivalent private label brand name) and no more than one third are to be an Alcon brand;
- Has refractive astigmatism no higher than -0.75DC in each eye;
- Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).
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 or ocular 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
- Complete Eye Care of Medina
- Sacco Eye Group
- Athens Eye Care
- ProCare Vision Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lens A, Then Lens B
Lens B, Then Lens A
Arm Description
Participants will wear Lens A for one month and then cross over to wear Lens B for one month.
Participants will wear Lens B for one month and then cross over to wear Lens A for one month.
Outcomes
Primary Outcome Measures
Subjective Ratings on Lens Handling on Removal
Subjective Ratings on Lens handling on removal (0-10 scale, 0.5 steps; 10=very easy, 0=very difficult)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05114564
Brief Title
Evaluation of the Performance of Monthly Replacement Sphere Lens Designs in Habitual Soft Contact Lens Wearers
Official Title
Evaluation of the Performance of Monthly Replacement Sphere Lens Designs in Habitual Soft Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
April 22, 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
No
5. Study Description
Brief Summary
The objective of the study is to evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for one month.
Detailed Description
This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different FRP lens types. Each lens type will be worn for approximately one month.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lens A, Then Lens B
Arm Type
Experimental
Arm Description
Participants will wear Lens A for one month and then cross over to wear Lens B for one month.
Arm Title
Lens B, Then Lens A
Arm Type
Experimental
Arm Description
Participants will wear Lens B for one month and then cross over to wear Lens A for one month.
Intervention Type
Device
Intervention Name(s)
Lens A (comfilcon A lens)
Intervention Description
1 month
Intervention Type
Device
Intervention Name(s)
Lens B (lehfilcon A lens)
Intervention Description
1 month
Primary Outcome Measure Information:
Title
Subjective Ratings on Lens Handling on Removal
Description
Subjective Ratings on Lens handling on removal (0-10 scale, 0.5 steps; 10=very easy, 0=very difficult)
Time Frame
Day 27
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Self-reports having a full eye examination in the previous two years;
Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens brand is restricted such that no more than one third are to be the Biofinity brand (or their equivalent private label brand name) and no more than one third are to be an Alcon brand;
Has refractive astigmatism no higher than -0.75DC in each eye;
Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).
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 or ocular 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, PhD FCOptom
Organizational Affiliation
Centre for Ocular Research and Education
Official's Role
Study Director
Facility Information:
Facility Name
Complete Eye Care of Medina
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
Sacco Eye Group
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Athens Eye Care
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
ProCare Vision Center
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Performance of Monthly Replacement Sphere Lens Designs in Habitual Soft Contact Lens Wearers
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