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

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04668989
• Collaborator: (none)
• Enrollment: 68
• Locations: 4
• Arms: 2
• Actual Duration (Months): 3.2
• Patients Per Site: 17
• Patients Per Site Per Month: 5.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: stenfilcon A - (Test lens); Device: kalifilcon A - (Control Lens)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers
• Actual Study Start Date: Nov 1, 2020
• Actual Primary Completion Date: Feb 5, 2021
• Actual Study Completion Date: Feb 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: stenfilcon A - (Test lens) Subjects will be randomized to wear test lenses for one week then cross-over to the control lenses for one week.	Device: stenfilcon A - (Test lens); Subjects will be randomized to wear test lenses for one week.; Device: kalifilcon A - (Control Lens); Subjects will be randomized to wear control lenses for one week.
Active Comparator: kalifilcon A - (Control Lens) Subjects will be randomized to wear control lenses for one week then cross-over to the test lenses for one week.	Device: stenfilcon A - (Test lens); Subjects will be randomized to wear test lenses for one week.; Device: kalifilcon A - (Control Lens); Subjects will be randomized to wear control lenses for one week.

Outcome Measures

Primary Outcome Measures

1. Lens Wettability [Baseline - after 2 hours of lens wear]

   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)

2. Lens Wettability [1 week]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Complete Eye Care of Medina	Medina	Minnesota	United States	55340
2	Sacco Eye Group, PLLC	Vestal	New York	United States	13850
3	Athens Eye Care	Athens	Ohio	United States	45701
4	Nittany Eye Associates	College	Pennsylvania	United States	16801

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Study Director: Lyndon Jones, PhD, Centre for Ocular Research & Education

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 23, 2020

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04668989
• Other Study ID Numbers: EX-MKTG-118
• First Posted: Dec 16, 2020
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• 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

Pre-assignment Detail	68 participants were screened, 2 subjects discontinued, and 66 subjects were dispensed with the study lenses.

Arm/Group Title	Stenfilcon A - (Test Lens) Then Kalifilcon A (Control Lens)	Kalifilcon A - (Control Lens) Then Stenfilcon A - (Test Lens)
Arm/Group Description	Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week. stenfilcon A - (Test lens) kalifilcon A - (Control lens)	Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week. stenfilcon A - (Test lens) kalifilcon A - (Control Lens)
Period Title: First Intervention
STARTED	36	30
COMPLETED	36	29
NOT COMPLETED	0	1
Period Title: First Intervention
STARTED	36	29
COMPLETED	36	28
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week. stenfilcon A - (Test lens) kalifilcon A - (Control Lens)
Overall Participants	68
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	68 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.3 (8.2)
Sex: Female, Male (Count of Participants)
Female	47 69.1%
Male	21 30.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	68 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A - (Test Lens)	Kalifilcon A - (Control Lens)
Arm/Group Description	Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week. stenfilcon A - (Test lens)	Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week. kalifilcon A - (Control lens)
Measure Participants	64	64
Mean (Standard Deviation) [units on a scale]	3.7 (0.4)	3.7 (0.5)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A - (Test Lens)	Kalifilcon A - (Control Lens)
Arm/Group Description	Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week. stenfilcon A - (Test lens)	Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week. kalifilcon A - (Control lens)
Measure Participants	64	64
Mean (Standard Deviation) [units on a scale]	3.5 (0.6)	3.5 (0.6)

Adverse Events

Time Frame	From dispense up to 1 week on each study lens, a total of 2 weeks
Arm/Group Title	Stenfilcon A - (Test Lens)		Kalifilcon A - (Control Lens)
Arm/Group Description	Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week.		Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week.
All Cause Mortality
	Stenfilcon A - (Test Lens)		Kalifilcon A - (Control Lens)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/66 (0%)
Serious Adverse Events
	Stenfilcon A - (Test Lens)		Kalifilcon A - (Control Lens)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/66 (0%)
Other (Not Including Serious) Adverse Events
	Stenfilcon A - (Test Lens)		Kalifilcon A - (Control Lens)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/66 (1.5%)		0/66 (0%)
Eye disorders
Corneal Abrasion	1/66 (1.5%)	1	0/66 (0%)	0

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.