Trial Outcomes & Findings for To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear (NCT NCT05333965)

Results Overview

Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

1 month

Results posted on

2023-10-23

There were 27 people screened and 26 were dispensed with study products. Two participants discontinued and 24 completed the study.

Participant milestones
Measure	Lens A, Then Lens B Participants wore Lens A for one month and then crossed over to wear Lens B for one month. Each Lens type was worn on a daily wear basis for one month.	Lens B, Then Lens A Participants wore Lens B for one month and then crossed over to wear Lens A for one month. Each Lens type was worn on a daily wear basis for one month.
First Intervention STARTED	13	13
First Intervention COMPLETED	13	11
First Intervention NOT COMPLETED	0	2
Second Intervention STARTED	13	11
Second Intervention COMPLETED	13	11
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal
Measure	Lens A, Then Lens B Participants wore Lens A for one month and then crossed over to wear Lens B for one month. Each Lens type was worn on a daily wear basis for one month.	Lens B, Then Lens A Participants wore Lens B for one month and then crossed over to wear Lens A for one month. Each Lens type was worn on a daily wear basis for one month.
First Intervention Adverse Event	0	1
First Intervention Withdrawal by Subject	0	1

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Analysis Population n=24 Participants Out of 26 participants, 2 of them discontinued. Therefore, overall base participants (Analysis population) are 24.
Age, Categorical <=18 years	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=24 Participants
Age, Continuous	31.4 years STANDARD_DEVIATION 14.1 • n=24 Participants
Sex: Female, Male Female	15 Participants n=24 Participants
Sex: Female, Male Male	9 Participants n=24 Participants

Timeframe: 1 month

Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied)

Outcome measures
Measure	Lens A n=24 Participants Participants wore Lens A for 1 month.	Lens B n=24 Participants Participants wore Lens B for 1 month.
Lens Handling on Lens Removal	8.4 units on a scale Standard Deviation 2.3	8.9 units on a scale Standard Deviation 1.3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Lens A n=26 participants at risk Participants wore Lens A for 1 month.	Lens B n=26 participants at risk Participants wore Lens B for 1 month.
Eye disorders Significant Ocular Redness	0.00% 0/26 • From dispense up to one month on each study lens, for total of two months Enrollment population (n=26)	3.8% 1/26 • Number of events 2 • From dispense up to one month on each study lens, for total of two months Enrollment population (n=26)
Eye disorders asymptomatic corneal infiltrate keratitis	0.00% 0/26 • From dispense up to one month on each study lens, for total of two months Enrollment population (n=26)	3.8% 1/26 • Number of events 2 • From dispense up to one month on each study lens, for total of two months Enrollment population (n=26)

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