Trial Outcomes & Findings for Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses (NCT NCT04195893)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

Day 1

Results posted on

2020-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Somofilcon A Then Etafilcon 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. somofilcon A: Contact Lens etafilcon A: Contact Lens	Etafilcon A Then Somofilcon 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. etafilcon A: Contact Lens somofilcon A: Contact Lens
First Intervention STARTED	27	29
First Intervention COMPLETED	27	29
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	27	29
Second Intervention COMPLETED	26	29
Second Intervention NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Somofilcon A Then Etafilcon 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. somofilcon A: Contact Lens etafilcon A: Contact Lens	Etafilcon A Then Somofilcon 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. etafilcon A: Contact Lens somofilcon A: Contact Lens
Second Intervention Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=56 Participants Total Participants
Age, Categorical <=18 years	0 Participants n=56 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=56 Participants
Age, Categorical >=65 years	0 Participants n=56 Participants
Age, Continuous	27.1 years STANDARD_DEVIATION 9.7 • n=56 Participants
Sex: Female, Male Female	46 Participants n=56 Participants
Sex: Female, Male Male	10 Participants n=56 Participants
Region of Enrollment Canada	56 participants n=56 Participants

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Lens Handling for Lens Insertion	9.3 units on a scale Standard Deviation 1.0	8.0 units on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: Day 3

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

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Lens Handling for Lens Insertion	9.3 units on a scale Standard Deviation 1.2	7.9 units on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: Day 5

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

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Lens Handling for Lens Insertion	9.2 units on a scale Standard Deviation 1.3	8.1 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: 1 Week

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

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Lens Handling for Lens Insertion	9.4 units on a scale Standard Deviation 0.8	8.1 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Lens Handling for Lens Removal	9.4 units on a scale Standard Deviation 1.0	9.3 units on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: Day 3

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

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Lens Handling for Lens Removal	9.2 units on a scale Standard Deviation 1.0	9.2 units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: Day 5

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

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Lens Handling for Lens Removal	9.3 units on a scale Standard Deviation 1.0	9.1 units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Lens Handling for Lens Removal	9.4 units on a scale Standard Deviation 0.7	9.3 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Lens Centration	0.8 units on a scale Standard Deviation 0.5	0.7 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Lens Centration	0.7 units on a scale Standard Deviation 0.6	0.8 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline (after 10 minutes of lens fitting)

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

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Post-blink Movement	0.3 millimeters Standard Deviation 0.1	0.3 millimeters Standard Deviation 0.1

SECONDARY outcome

Timeframe: 1 -week

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

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Post-blink Movement	0.3 millimeters Standard Deviation 0.1	0.3 millimeters Standard Deviation 0.1

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Somofilcon A n=55 Participants Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens	Etafilcon A n=55 Participants Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens
Push-up Tightness	51 units on a scale Standard Deviation 5	49 units on a scale Standard Deviation 5

SECONDARY outcome

Timeframe: 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)