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Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
somofilcon A
verofilcon 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

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-

A person is eligible for inclusion in the study if he/she:

  1. Is at least 17 years of age 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. Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
  5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
  6. Has an astigmatism of ≤ 1.00 D in subjective refraction;
  7. Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
  8. Demonstrates an acceptable fit with the study lenses;
  9. Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.

Exclusion Criteria:

-

A person may be excluded from the study if he/she:

  1. Is participating in any concurrent clinical or research study;
  2. Has any known active* ocular disease and/or infection;
  3. Has a systemic 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 a study outcome variable;
  5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  6. Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
  7. Is aphakic;
  8. Has undergone refractive error surgery;
  9. Is an employee of the Centre for Ocular Research & Education;
  10. Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or MIKI (EX-MKTG-114) Study;
  11. Has participated in any clinical trials within a week prior to the study.

Sites / Locations

  • University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

somofilcon A

verofilcon A

Arm Description

Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to verofilcon A daily disposable lenses for one week.

Subjects will be randomized to wear verofilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.

Outcomes

Primary Outcome Measures

Subjective Ratings for Lens Handling for Lens Insertion
Subjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy).
Subjective Ratings for Lens Handling for Lens Removal
Subjective ratings for Lens handling for lens removal (0 - 10 integer scale), (0-very difficult, 10- very easy).

Secondary Outcome Measures

Lens Fit - Centration
Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus)
Lens Fit - Centration
Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus)
Lens Fit - Post-blink Movement
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in vivo at 8x magnification in primary gaze, in 0.1mm steps
Lens Fit - Post-blink Movement
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in vivo at 8x magnification in primary gaze, in 0.1mm steps
Lens Fit - Lens Push-up Tightness
The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement
Lens Fit - Lens Push-up Tightness
The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement

Full Information

First Posted
March 9, 2020
Last Updated
February 10, 2022
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04305912
Brief Title
Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses
Official Title
Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
August 28, 2021 (Actual)
Study Completion Date
August 30, 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
No

5. Study Description

Brief Summary
The objective of the study is to evaluate and compare the performance of verofilcon A to somofilcon A when worn on a daily disposable modality over a period of approximately one week each.
Detailed Description
The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates somofilcon A (test lens) and verofilcon A (control lens).

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
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
somofilcon A
Arm Type
Experimental
Arm Description
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to verofilcon A daily disposable lenses for one week.
Arm Title
verofilcon A
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear verofilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.
Intervention Type
Device
Intervention Name(s)
somofilcon A
Other Intervention Name(s)
Clariti 1 Day
Intervention Description
Subjects will be randomized to wear somofilcon A daily disposable lenses.
Intervention Type
Device
Intervention Name(s)
verofilcon A
Other Intervention Name(s)
Precision 1
Intervention Description
Subjects will be randomized to wear verofilcon A daily disposable lenses.
Primary Outcome Measure Information:
Title
Subjective Ratings for Lens Handling for Lens Insertion
Description
Subjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy).
Time Frame
1 week
Title
Subjective Ratings for Lens Handling for Lens Removal
Description
Subjective ratings for Lens handling for lens removal (0 - 10 integer scale), (0-very difficult, 10- very easy).
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Lens Fit - Centration
Description
Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus)
Time Frame
Baseline
Title
Lens Fit - Centration
Description
Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus)
Time Frame
1-week
Title
Lens Fit - Post-blink Movement
Description
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in vivo at 8x magnification in primary gaze, in 0.1mm steps
Time Frame
Baseline
Title
Lens Fit - Post-blink Movement
Description
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in vivo at 8x magnification in primary gaze, in 0.1mm steps
Time Frame
1-week
Title
Lens Fit - Lens Push-up Tightness
Description
The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement
Time Frame
Baseline
Title
Lens Fit - Lens Push-up Tightness
Description
The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement
Time Frame
1-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - A person is eligible for inclusion in the study if he/she: Is at least 17 years of age 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; Habitually wears soft contact lenses in daily wear, for minimum of 6-months; Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses; Has an astigmatism of ≤ 1.00 D in subjective refraction; Can be fit with study contact lenses with a power between -2.00 and -5.00 DS; Demonstrates an acceptable fit with the study lenses; Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study. Exclusion Criteria: - A person may be excluded from the study if he/she: Is participating in any concurrent clinical or research study; Has any known active* ocular disease and/or infection; 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 a study outcome variable; Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient; Is aphakic; Has undergone refractive error surgery; Is an employee of the Centre for Ocular Research & Education; Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or MIKI (EX-MKTG-114) Study; Has participated in any clinical trials within a week prior to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD FCOptom
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses

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