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Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use

Primary Purpose

Ametropia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lens A (comfilcon A lens)
Lens B (lehfilcon A lens)
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ametropia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Self-reports having a full eye examination in the previous two years;
  5. 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;
  6. Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
  7. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
  8. Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum;
  9. Has refractive astigmatism no higher than -0.75DC in each eye;
  10. 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:

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

Sites / Locations

  • Coan Eye Care
  • Nittany Eye Associate
  • Eyes on Sheppard Clinic
  • Spadina Optometry

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 will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult)

Secondary Outcome Measures

Full Information

First Posted
December 8, 2021
Last Updated
July 24, 2023
Sponsor
Coopervision, Inc.
Collaborators
CORE
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1. Study Identification

Unique Protocol Identification Number
NCT05166902
Brief Title
Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use
Official Title
Evaluation of Monthly Replacement Lens Designs in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
July 9, 2022 (Actual)
Study Completion Date
July 9, 2022 (Actual)

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
To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-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
Ametropia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (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 will be measured on a scale of 0-10, 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 was restricted such that no more than one third were to be Biofinity Energys brand (or their equivalent private label brand name) and no more than one third were to be 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
David Wilkinson
Organizational Affiliation
Spadina Optometry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roxanne Achong-Coan
Organizational Affiliation
Coan Eyecare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fiona Soong
Organizational Affiliation
Eyes on Sheppard Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mike Cymbor
Organizational Affiliation
Nittany Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coan Eye Care
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Nittany Eye Associate
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
168801
Country
United States
Facility Name
Eyes on Sheppard Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2N 3A4
Country
Canada
Facility Name
Spadina Optometry
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V 3E7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use

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