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

Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses (BEAGLE 2)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04195893

Enrollment

Registered

2019-12-12

Start date

2019-11-24

Completion date

2020-03-11

Last updated

2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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.

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).

Interventions

DEVICEsomofilcon A

Contact Lens

DEVICEetafilcon A

Contact Lens

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
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).

Countries

Canada

Participant flow

Participants by arm

Arm	Count
Overall Study Total Participants	56
Total	56

Withdrawals & dropouts

Period	Reason	FG000	FG001
Second Intervention	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Overall Study	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	56 Participants	—
Age, Continuous	27.1 years STANDARD_DEVIATION 9.7	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Canada	56 participants	—
Sex: Female, Male Female	46 Participants	—
Sex: Female, Male Male	10 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 55	0 / 55
other Total, other adverse events	2 / 55	0 / 55
serious Total, serious adverse events	0 / 55	0 / 55

Outcome results

Primary

Lens Handling for Lens Insertion

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

Time frame: Day 1

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Lens Handling for Lens Insertion	9.3 units on a scale	Standard Deviation 1
Etafilcon A	Lens Handling for Lens Insertion	8.0 units on a scale	Standard Deviation 1.9

Primary

Lens Handling for Lens Insertion

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

Time frame: Day 3

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Lens Handling for Lens Insertion	9.3 units on a scale	Standard Deviation 1.2
Etafilcon A	Lens Handling for Lens Insertion	7.9 units on a scale	Standard Deviation 2.4

Primary

Lens Handling for Lens Insertion

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

Time frame: Day 5

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Lens Handling for Lens Insertion	9.2 units on a scale	Standard Deviation 1.3
Etafilcon A	Lens Handling for Lens Insertion	8.1 units on a scale	Standard Deviation 2.3

Primary

Lens Handling for Lens Insertion

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

Time frame: 1 Week

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Lens Handling for Lens Insertion	9.4 units on a scale	Standard Deviation 0.8
Etafilcon A	Lens Handling for Lens Insertion	8.1 units on a scale	Standard Deviation 1.7

Primary

Lens Handling for Lens Removal

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

Time frame: Day 1

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Lens Handling for Lens Removal	9.4 units on a scale	Standard Deviation 1
Etafilcon A	Lens Handling for Lens Removal	9.3 units on a scale	Standard Deviation 1.4

Primary

Lens Handling for Lens Removal

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

Time frame: Day 3

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Lens Handling for Lens Removal	9.2 units on a scale	Standard Deviation 1
Etafilcon A	Lens Handling for Lens Removal	9.2 units on a scale	Standard Deviation 1.3

Primary

Lens Handling for Lens Removal

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

Time frame: Day 5

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Lens Handling for Lens Removal	9.3 units on a scale	Standard Deviation 1
Etafilcon A	Lens Handling for Lens Removal	9.1 units on a scale	Standard Deviation 1.3

Primary

Lens Handling for Lens Removal

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

Time frame: 1 week

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Lens Handling for Lens Removal	9.4 units on a scale	Standard Deviation 0.7
Etafilcon A	Lens Handling for Lens Removal	9.3 units on a scale	Standard Deviation 0.9

Secondary

Lens Centration

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)

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Lens Centration	0.8 units on a scale	Standard Deviation 0.5
Etafilcon A	Lens Centration	0.7 units on a scale	Standard Deviation 0.7

Secondary

Lens Centration

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

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Lens Centration	0.7 units on a scale	Standard Deviation 0.6
Etafilcon A	Lens Centration	0.8 units on a scale	Standard Deviation 0.6

Secondary

Post-blink Movement

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

Time frame: Baseline (after 10 minutes of lens fitting)

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Post-blink Movement	0.3 millimeters	Standard Deviation 0.1
Etafilcon A	Post-blink Movement	0.3 millimeters	Standard Deviation 0.1

Secondary

Post-blink Movement

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

Time frame: 1 -week

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Post-blink Movement	0.3 millimeters	Standard Deviation 0.1
Etafilcon A	Post-blink Movement	0.3 millimeters	Standard Deviation 0.1

Secondary

Push-up Tightness

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)

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Push-up Tightness	51 units on a scale	Standard Deviation 5
Etafilcon A	Push-up Tightness	49 units on a scale	Standard Deviation 5

Secondary

Push-up Tightness

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

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A	Push-up Tightness	52 units on a scale	Standard Deviation 6
Etafilcon A	Push-up Tightness	48 units on a scale	Standard Deviation 7

Other Pre-specified