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Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently

Primary Purpose

Myopia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control Contact Lens (stenfilcon A)
Test Contact Lens (senofilcon A)
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 - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Is between 18 and 35 years of age (inclusively) 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; 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; Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears soft contact lenses, for the past 3 months minimum; No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day. 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 -1.00 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 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

  • Kannarr Eye CareRecruiting
  • Complete Eye Care of Medina/Complete Vision SolutionsRecruiting
  • Nittany Eye AssociateRecruiting
  • West Bay AssociateRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control Contact Lens, Then Test Contact Lens

Test Contact Lens, Then Control Contact Lens

Arm Description

Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week.

Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week.

Outcomes

Primary Outcome Measures

Lens Handling on Removal
Lens Handling on Removal using a 0-100 scale (0= very difficult, 100= very easy)

Secondary Outcome Measures

Full Information

First Posted
March 28, 2023
Last Updated
April 19, 2023
Sponsor
Coopervision, Inc.
Collaborators
CORE
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1. Study Identification

Unique Protocol Identification Number
NCT05805150
Brief Title
Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently
Official Title
Performance Evaluation of Different Daily Disposable Contact Lenses in Habitual Lens Wearers Who Report Frequent Use of Digital Devices
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (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 goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.
Detailed Description
This study is prospective, bilateral eye, double masked, randomized, 1 week cross-over, daily wear design involving in two different daily disposable lens types. Each lens type will be worn for approximately one week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Contact Lens, Then Test Contact Lens
Arm Type
Experimental
Arm Description
Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week.
Arm Title
Test Contact Lens, Then Control Contact Lens
Arm Type
Experimental
Arm Description
Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week.
Intervention Type
Device
Intervention Name(s)
Control Contact Lens (stenfilcon A)
Intervention Description
One week wear
Intervention Type
Device
Intervention Name(s)
Test Contact Lens (senofilcon A)
Intervention Description
One week wear
Primary Outcome Measure Information:
Title
Lens Handling on Removal
Description
Lens Handling on Removal using a 0-100 scale (0= very difficult, 100= very easy)
Time Frame
6 days of wear

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 between 18 and 35 years of age (inclusively) 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; 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; Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears soft contact lenses, for the past 3 months minimum; No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day. 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 -1.00 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 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,MSc,FAAO
Phone
9256213761
Email
javega@coopervision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina Wesley, OD,MS,FAAO
Organizational Affiliation
Complete Eye Care of Medina/Complete Vision Solutions
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mike Cymbor
Organizational Affiliation
Nittany Eye Associate
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shane Kannarr
Organizational Affiliation
Shane Kannarr Eye Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen M Montaquila
Organizational Affiliation
West Bay Eye Associate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shane Kannarr
Facility Name
Complete Eye Care of Medina/Complete Vision Solutions
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina Wesley, OD,MS,FAAO
Facility Name
Nittany Eye Associate
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Cymbor
Facility Name
West Bay Associate
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen M Montaquila

12. IPD Sharing Statement

Learn more about this trial

Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently

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