Trial Outcomes & Findings for Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI) (NCT NCT04492397)

Results Overview

Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

1 week

Results posted on

2021-06-23

Participant Flow

Forty-one subjects were screened and 35 subjects started and completed the study.

Participant milestones

Participant milestones
Measure	Test Contact Lens the Control Contact Lens Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Test Contact Lens: Subjects will be randomized to wear test lenses. Control Contact Lens: Subjects will be randomized to wear control lenses.	Control Contact Lens Then Test Contact Lens Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Test Contact Lens: Subjects will be randomized to wear test lenses. Control Contact Lens: Subjects will be randomized to wear control lenses.
First Intervention STARTED	17	18
First Intervention COMPLETED	17	18
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	17	18
Second Intervention COMPLETED	17	18
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=41 Participants Subjects will be randomized to wear control lenses and test lenses for one week. Contact lenses: Test Contact Lens Contact lenses: Control Contact Lens
Age, Categorical <=18 years	2 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=41 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants
Age, Continuous	25.8 years STANDARD_DEVIATION 9.3 • n=41 Participants
Sex: Female, Male Female	31 Participants n=41 Participants
Sex: Female, Male Male	10 Participants n=41 Participants
Region of Enrollment Canada	41 participants n=41 Participants

PRIMARY outcome

Timeframe: 1 week

Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)

Outcome measures

Outcome measures
Measure	Test Contact Lens n=35 Participants Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Control Contact Lens n=35 Participants Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Overall Lens Fit Acceptance	3.71 units on a scale Standard Deviation 0.33	3.73 units on a scale Standard Deviation 0.35

SECONDARY outcome

Timeframe: Baseline

Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive \& occasionally encroaching limbus")

Outcome measures

Outcome measures
Measure	Test Contact Lens n=35 Participants Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Control Contact Lens n=35 Participants Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Lens Centration	0.40 units on a scale Standard Deviation 0.50	0.29 units on a scale Standard Deviation 0.52

SECONDARY outcome

Timeframe: 1 week

Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive \& occasionally encroaching limbus")

Outcome measures

Outcome measures
Measure	Test Contact Lens n=35 Participants Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Control Contact Lens n=35 Participants Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Lens Centration	0.17 units on a scale Standard Deviation 0.38	0.20 units on a scale Standard Deviation 0.47

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Test Contact Lens n=35 Participants Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Control Contact Lens n=35 Participants Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Post-blink Movement	0.20 mm Standard Deviation 0.06	0.23 mm Standard Deviation 0.06

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Test Contact Lens n=35 Participants Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Control Contact Lens n=35 Participants Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Post-blink Movement	0.20 mm Standard Deviation 0.05	0.23 mm Standard Deviation 0.07

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Test Contact Lens n=35 Participants Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Control Contact Lens n=35 Participants Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Push-up Tightness	51 units on a scale Standard Deviation 5	49 units on a scale Standard Deviation 6

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Outcome measures
Measure	Test Contact Lens n=35 Participants Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Control Contact Lens n=35 Participants Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Push-up Tightness	50 units on a scale Standard Deviation 4	48 units on a scale Standard Deviation 4

Adverse Events

Test Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jose A. Vega, O.D., MSc, FAAO

Coopervision

Phone: 9256213761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place