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Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
stenfilcon A - (Test lens)
kalifilcon A - (Control Lens)
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 - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Is at least 18 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Self reports having a full eye examination in the previous two years;
  4. Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
  5. Is willing and able to follow instructions and maintain the appointment schedule;
  6. Habitually wears soft contact lenses, for the past 3 months minimum;
  7. Has refractive astigmatism no higher than -0.75DC in each eye;
  8. 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:

  1. Is participating in any concurrent clinical or research study;
  2. Habitually wears one of the study contact lenses;
  3. Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
  4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
  6. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
  7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
  8. Has undergone refractive error surgery or intraocular surgery.

Sites / Locations

  • Complete Eye Care of Medina
  • Sacco Eye Group, PLLC
  • Athens Eye Care
  • Nittany Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

stenfilcon A - (Test lens)

kalifilcon A - (Control Lens)

Arm Description

Subjects will be randomized to wear test lenses for one week then cross-over to the control lenses for one week.

Subjects will be randomized to wear control lenses for one week then cross-over to the test lenses for one week.

Outcomes

Primary Outcome Measures

Lens Wettability
Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)
Lens Wettability
Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)

Secondary Outcome Measures

Full Information

First Posted
December 4, 2020
Last Updated
September 14, 2021
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04668989
Brief Title
Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers
Official Title
Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
February 5, 2021 (Actual)
Study Completion Date
February 5, 2021 (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 main objective of the study is to refit existing soft lens wearers with two different daily disposable contact lens types, Lens A and Lens B, to determine their performance after one week of wear.
Detailed Description
This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

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
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stenfilcon A - (Test lens)
Arm Type
Experimental
Arm Description
Subjects will be randomized to wear test lenses for one week then cross-over to the control lenses for one week.
Arm Title
kalifilcon A - (Control Lens)
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear control lenses for one week then cross-over to the test lenses for one week.
Intervention Type
Device
Intervention Name(s)
stenfilcon A - (Test lens)
Intervention Description
Subjects will be randomized to wear test lenses for one week.
Intervention Type
Device
Intervention Name(s)
kalifilcon A - (Control Lens)
Intervention Description
Subjects will be randomized to wear control lenses for one week.
Primary Outcome Measure Information:
Title
Lens Wettability
Description
Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)
Time Frame
Baseline - after 2 hours of lens wear
Title
Lens Wettability
Description
Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Is at least 18 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, 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; 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; Habitually wears one of the study contact lenses; 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, PhD
Organizational Affiliation
Centre for Ocular Research & 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, PLLC
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
Nittany Eye Associates
City
College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers

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