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Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers

Primary Purpose

Myopia, Hyperopia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lens A (fanfilcon A)
Lens B (lotrafilcon B)
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Is at least 18 years of age and no older than 39 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; 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 spherical soft contact lenses, for the past 3 months minimum: It is preferred that all participants are habitual frequent replacement lens wearers. However, if this is not possible then no more than 5 participants can be habitual daily disposable lens wearers at each site, the rest must be habitual frequent replacement lens wearers; - For the frequent replacement wearers: No more than 3 can be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 can be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site; 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

  • Insight Eye Care

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 wear Lens B for one month.

Participants will wear Lens B one month and then wear Lens A for one month.

Outcomes

Primary Outcome Measures

Lens Handling on Removal
Participants will measure subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens will be collected in the at-home diary on Day 27.

Secondary Outcome Measures

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
Coopervision, Inc.
Collaborators
CORE
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1. Study Identification

Unique Protocol Identification Number
NCT06098339
Brief Title
Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers
Official Title
Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
Collaborators
CORE

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 purpose of this study is to compare the clinical performance of two different monthly replacement lens in habitual spherical soft lens wearers.
Detailed Description
This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each participant is approximately 3 months.

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
45 (Anticipated)

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 wear Lens B for one month.
Arm Title
Lens B, then Lens A
Arm Type
Experimental
Arm Description
Participants will wear Lens B one month and then wear Lens A for one month.
Intervention Type
Device
Intervention Name(s)
Lens A (fanfilcon A)
Intervention Description
Daily wear for one month
Intervention Type
Device
Intervention Name(s)
Lens B (lotrafilcon B)
Intervention Description
Daily wear for one month
Primary Outcome Measure Information:
Title
Lens Handling on Removal
Description
Participants will measure subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens will be collected in the at-home diary on Day 27.
Time Frame
Day 27

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is at least 18 years of age and no older than 39 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; 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 spherical soft contact lenses, for the past 3 months minimum: It is preferred that all participants are habitual frequent replacement lens wearers. However, if this is not possible then no more than 5 participants can be habitual daily disposable lens wearers at each site, the rest must be habitual frequent replacement lens wearers; - For the frequent replacement wearers: No more than 3 can be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 can be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose A Vega, OD PhD FAAO
Phone
(925) 621-3761
Email
JVega2@coopervision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn MacNeil
Organizational Affiliation
Insight Eye Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Insight Eye Care
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3S1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers

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