Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04195893
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 15.8

Study Details

Study Description

Brief Summary

The objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.

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

Detailed Description

The study is a prospective, double masked (investigator and participant), bilateral, randomized, cross-over dispensing study, which evaluates somofilcon A (test lens) and etafilcon A (control lens).

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses (BEAGLE 2)
• Actual Study Start Date: Nov 24, 2019
• Actual Primary Completion Date: Feb 12, 2020
• Actual Study Completion Date: Mar 11, 2020

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 etafilcon A daily disposable lenses for one week.	Device: somofilcon A; Contact Lens; Other Names: Clariti 1-Day
Active Comparator: etafilcon A Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.	Device: etafilcon A; Contact Lens; Other Names: 1-Day Acuvue Moist

Outcome Measures

Primary Outcome Measures

1. Lens Handling for Lens Insertion [Day 1]

   Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

2. Lens Handling for Lens Insertion [Day 3]

   Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

3. Lens Handling for Lens Insertion [Day 5]

   Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

4. Lens Handling for Lens Insertion [1 Week]

   Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

5. Lens Handling for Lens Removal [Day 1]

   Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

6. Lens Handling for Lens Removal [Day 3]

   Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

7. Lens Handling for Lens Removal [Day 5]

   Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

8. Lens Handling for Lens Removal [1 week]

   Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)

Secondary Outcome Measures

1. Lens Centration [Baseline (after 10 minutes of lens fitting)]

   Lens 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 Centration [1 week]

   Lens 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. Post-blink Movement [Baseline (after 10 minutes of lens fitting)]

   Post-blink movement in primary gaze, in 0.1mm steps

4. Post-blink Movement [1 -week]

   Post-blink movement in primary gaze, in 0.1mm steps

5. Push-up Tightness [Baseline (after 10 minutes of lens fitting)]

   Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)

6. Push-up Tightness [1 week]

   Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)

Other Outcome Measures

1. Subjective Ratings of Comfort After Lens Insertion [Baseline]

   Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).

2. Subjective Ratings of Comfort After Lens Insertion [1 Day]

   Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).

3. Subjective Ratings of Comfort After Lens Insertion [Day 3]

   Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).

4. Subjective Ratings of Comfort After Lens Insertion [Day 5]

   Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).

5. Subjective Ratings of Comfort After Lens Insertion [1-Week]

   Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects will only be eligible for the study if:

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 silicone hydrogel frequent replacement soft contact lenses, 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. Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;

7. Demonstrates an acceptable fit with the study lenses;

8. Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.

Exclusion Criteria:

• Subjects will not be eligible to take part in the study if:

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 (verbal confirmation at the screening visit);

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 BEAGLE (EX-MKTG-104) 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, University of Waterloo

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 2, 2019

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04195893
• Other Study ID Numbers: EX-MKTG-112
• First Posted: Dec 12, 2019
• Last Update Posted: Aug 18, 2020
• Last Verified: Aug 1, 2020

• 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 Etafilcon A	Etafilcon A Then Somofilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week. somofilcon A: Contact Lens etafilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week. etafilcon A: Contact Lens somofilcon A: Contact Lens
Period Title: First Intervention
STARTED	27	29
COMPLETED	27	29
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	27	29
COMPLETED	26	29
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Total Participants
Overall Participants	56
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	56 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.1 (9.7)
Sex: Female, Male (Count of Participants)
Female	46 82.1%
Male	10 17.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Canada	56 100%

Outcome Measures

1. Primary Outcome

Title	Lens Handling for Lens Insertion
Description	Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.3 (1.0)	8.0 (1.9)

2. Primary Outcome

Title	Lens Handling for Lens Insertion
Description	Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.3 (1.2)	7.9 (2.4)

3. Primary Outcome

Title	Lens Handling for Lens Insertion
Description	Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.2 (1.3)	8.1 (2.3)

4. Primary Outcome

Title	Lens Handling for Lens Insertion
Description	Lens handling for lens insertion (subjective rating; 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	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.4 (0.8)	8.1 (1.7)

5. Primary Outcome

Title	Lens Handling for Lens Removal
Description	Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.4 (1.0)	9.3 (1.4)

6. Primary Outcome

Title	Lens Handling for Lens Removal
Description	Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.2 (1.0)	9.2 (1.3)

7. Primary Outcome

Title	Lens Handling for Lens Removal
Description	Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.3 (1.0)	9.1 (1.3)

8. Primary Outcome

Title	Lens Handling for Lens Removal
Description	Lens handling for lens removal (subjective rating; 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	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.4 (0.7)	9.3 (0.9)

9. Secondary Outcome

Title	Lens Centration
Description	Lens 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 (after 10 minutes of lens fitting)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	0.8 (0.5)	0.7 (0.7)

10. Secondary Outcome

Title	Lens Centration
Description	Lens 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

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	0.7 (0.6)	0.8 (0.6)

11. Secondary Outcome

Title	Post-blink Movement
Description	Post-blink movement in primary gaze, in 0.1mm steps
Time Frame	Baseline (after 10 minutes of lens fitting)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [millimeters]	0.3 (0.1)	0.3 (0.1)

12. Secondary Outcome

Title	Post-blink Movement
Description	Post-blink movement in primary gaze, in 0.1mm steps
Time Frame	1 -week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [millimeters]	0.3 (0.1)	0.3 (0.1)

13. Secondary Outcome

Title	Push-up Tightness
Description	Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
Time Frame	Baseline (after 10 minutes of lens fitting)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	51 (5)	49 (5)

14. Secondary Outcome

Title	Push-up Tightness
Description	Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	52 (6)	48 (7)

15. Other Pre-specified Outcome

Title	Subjective Ratings of Comfort After Lens Insertion
Description	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.2 (1.0)	8.7 (1.8)

16. Other Pre-specified Outcome

Title	Subjective Ratings of Comfort After Lens Insertion
Description	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).
Time Frame	1 Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.1 (0.9)	8.9 (1.4)

17. Other Pre-specified Outcome

Title	Subjective Ratings of Comfort After Lens Insertion
Description	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.1 (1.2)	8.6 (1.7)

18. Other Pre-specified Outcome

Title	Subjective Ratings of Comfort After Lens Insertion
Description	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.2 (1.0)	8.9 (1.3)

19. Other Pre-specified Outcome

Title	Subjective Ratings of Comfort After Lens Insertion
Description	Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).
Time Frame	1-Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A	Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Measure Participants	55	55
Mean (Standard Deviation) [units on a scale]	9.0 (1.0)	8.1 (1.8)

Adverse Events

Time Frame	From baseline till 1 -week for each type of lenses, up to 2 weeks total
Arm/Group Title	Somofilcon A		Etafilcon A
Arm/Group Description	Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens		Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
All Cause Mortality
	Somofilcon A		Etafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)
Serious Adverse Events
	Somofilcon A		Etafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Somofilcon A		Etafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/55 (3.6%)		0/55 (0%)
Eye disorders
Conjuctival Staining	2/55 (3.6%)	2	0/55 (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.