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

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04305912
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.3
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: somofilcon A; Device: verofilcon A	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses
• Actual Study Start Date: Feb 19, 2020
• Actual Primary Completion Date: Aug 28, 2021
• Actual Study Completion Date: Aug 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: somofilcon A 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.	Device: somofilcon A; Subjects will be randomized to wear somofilcon A daily disposable lenses.; Other Names: Clariti 1 Day
Active Comparator: verofilcon A 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.	Device: verofilcon A; Subjects will be randomized to wear verofilcon A daily disposable lenses.; Other Names: Precision 1

Outcome Measures

Primary Outcome Measures

1. Subjective Ratings for Lens Handling for Lens Insertion [1 week]

   Subjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy).

2. Subjective Ratings for Lens Handling for Lens Removal [1 week]

   Subjective ratings for Lens handling for lens removal (0 - 10 integer scale), (0-very difficult, 10- very easy).

Secondary Outcome Measures

1. Lens Fit - Centration [Baseline]

   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)

2. Lens Fit - Centration [1-week]

   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)

3. Lens Fit - Post-blink Movement [Baseline]

   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

4. Lens Fit - Post-blink Movement [1-week]

   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

5. Lens Fit - Lens Push-up Tightness [Baseline]

   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

6. Lens Fit - Lens Push-up Tightness [1-week]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Waterloo	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Lyndon Jones, PhD FCOptom, University of Waterloo

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 16, 2020

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04305912
• Other Study ID Numbers: EX-MKTG-113
• First Posted: Mar 12, 2020
• Last Update Posted: Feb 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Somofilcon A Then Verofilcon A	Verofilcon A the Somofilcon A
Arm/Group 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.
Period Title: First Intervention
STARTED	26	25
COMPLETED	24	24
NOT COMPLETED	2	1
Period Title: First Intervention
STARTED	24	24
COMPLETED	24	23
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses and verofilcon A daily disposable lenses for one week.
Overall Participants	51
Age (Count of Participants)
<=18 years	1 2%
Between 18 and 65 years	50 98%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.8 (12.3)
Sex: Female, Male (Count of Participants)
Female	40 78.4%
Male	11 21.6%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Canada	51 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Verofilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.	Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
Measure Participants	47	47
Mean (Standard Deviation) [units on a scale]	9.3 (0.9)	9.2 (1.2)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Verofilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.	Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
Measure Participants	47	47
Mean (Standard Deviation) [units on a scale]	9.1 (1.3)	8.8 (1.9)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Verofilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.	Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
Measure Participants	47	47
Mean (Standard Deviation) [units on a scale]	0.7 (0.7)	0.4 (0.5)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

One subject missed follow-up assessment for lens-fit centration.

Arm/Group Title	Somofilcon A	Verofilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.	Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	0.5 (0.6)	0.3 (0.5)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Verofilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.	Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
Measure Participants	47	47
Mean (Standard Deviation) [mm]	0.2 (0.1)	0.2 (0.1)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Verofilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.	Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
Measure Participants	47	47
Mean (Standard Deviation) [mm]	0.2 (0.1)	0.2 (0.1)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Verofilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.	Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
Measure Participants	47	47
Mean (Standard Deviation) [units on a scale]	50 (4)	49 (5)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Verofilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.	Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
Measure Participants	47	47
Mean (Standard Deviation) [units on a scale]	51 (5)	51 (5)

Adverse Events

Time Frame	From dispense to 1 week on each lens, a total of two weeks.
Arm/Group Title	Somofilcon A		Verofilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.		Subjects will be randomized to wear verofilcon A daily disposable lenses for one week.
All Cause Mortality
	Somofilcon A		Verofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)
Serious Adverse Events
	Somofilcon A		Verofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Somofilcon A		Verofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/51 (3.9%)		1/51 (2%)
Eye disorders
Conjunctival Hyperemia	1/51 (2%)	1	0/51 (0%)	0
Mild Ocular Redness	1/51 (2%)	1	0/51 (0%)	0
Headache	0/51 (0%)	0	1/51 (2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.