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Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses.

Primary Purpose

Myopia

Status
Active
Phase
Not Applicable
Locations
International
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; 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

  • Coan Eye Care & Optical Boutique
  • Sacco Eye Group
  • Procare Vision
  • Insite Eye Care

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
NCT05805059
Brief Title
Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses.
Official Title
Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
September 8, 2023 (Anticipated)
Study Completion Date
September 8, 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 contact lenses.
Detailed Description
This study is a prospective, bilateral eye, double masked, randomized, 1-week crossover, daily wear design involving 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
60 (Actual)

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 of 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Sacco
Organizational Affiliation
Sacco Eye Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolyn McNeil
Organizational Affiliation
Insite Eye Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katherine Bickle
Organizational Affiliation
Procare Vision
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roxanne Achong-Coan
Organizational Affiliation
Coan Eye Care & Optical Boutique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coan Eye Care & Optical Boutique
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Sacco Eye Group
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Procare Vision
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
Insite Eye Care
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3S1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses.

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