Trial Outcomes & Findings for Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design (NCT NCT04952701)

Results Overview

Subjective ratings of comfort on insertion using a 0-10 scale, in 0.5 steps (0=- painful, 10- Can't feel the lenses).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

63 participants

Primary outcome timeframe

Day 1 after Lens Dispense Visit

Results posted on

2022-04-27

Participant milestones
Measure	Overall Study All subjects wore control lenses for two weeks and then wore Test lenses for two weeks. Control lenses: Control Multifocal lenses Test lenses: Test Multifocal lenses
Control Lens STARTED	63
Control Lens COMPLETED	59
Control Lens NOT COMPLETED	4
Test Lens STARTED	59
Test Lens COMPLETED	58
Test Lens NOT COMPLETED	1

Reasons for withdrawal
Measure	Overall Study All subjects wore control lenses for two weeks and then wore Test lenses for two weeks. Control lenses: Control Multifocal lenses Test lenses: Test Multifocal lenses
Control Lens Physician Decision	4
Test Lens Physician Decision	1

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Overall Study n=63 Participants All subjects wore control lenses for two weeks and then test lenses for two weeks.
Age, Categorical <=18 years	0 Participants n=63 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=63 Participants
Age, Categorical >=65 years	0 Participants n=63 Participants
Age, Continuous	53.9 years STANDARD_DEVIATION 6.2 • n=63 Participants
Sex: Female, Male Female	51 Participants n=63 Participants
Sex: Female, Male Male	12 Participants n=63 Participants
Region of Enrollment United States	63 participants n=63 Participants

Timeframe: Day 1 after Lens Dispense Visit

Subjective ratings of comfort on insertion using a 0-10 scale, in 0.5 steps (0=- painful, 10- Can't feel the lenses).

Outcome measures
Measure	Control Lens n=58 Participants All subjects wore control lenses for two weeks. Control lenses: Control Multifocal lenses	Test Lens n=58 Participants All subjects wore test lenses for two weeks. Test lenses: Test Multifocal lenses
Comfort on Insertion	9.2 units on a scale Standard Deviation 1.1	9.2 units on a scale Standard Deviation 1.0

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Control Lens n=63 participants at risk All subjects wore control lenses for two weeks and then wore Test lenses for two weeks. Control lenses: Control Multifocal lenses	Test Lens n=63 participants at risk After wearing control lenses for two weeks, all subjects wore test lenses for two weeks. Test lenses: Test Multifocal lenses
Eye disorders Light Sensitivity	3.2% 2/63 • Number of events 2 • From dispense up to 2 weeks on each study lens, a total of 4 weeks.	0.00% 0/63 • From dispense up to 2 weeks on each study lens, a total of 4 weeks.
Eye disorders Eye Irritation and Discomfort	0.00% 0/63 • From dispense up to 2 weeks on each study lens, a total of 4 weeks.	3.2% 2/63 • Number of events 2 • From dispense up to 2 weeks on each study lens, a total of 4 weeks.

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