Trial Outcomes & Findings for Multifocal Contact Lenses Fitting Methods Comparison (NCT NCT05734846)

Results Overview

Overall vision satisfaction for each lens was measured on a 0-100 point Visual Analog Scale (VAS), where 0=Extremely Unsatisfied and 100=Extremely Satisfied

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

One week

Results posted on

2024-01-10

Participant Flow

Twenty-five participants were screened and subsequently enrolled in the study.

Participant milestones

Participant milestones
Measure	Control Lenses, Then Test Lenses Participants first wore Control Lenses for 1 week (Period 1) and then wore Test Lenses for 1 week (Period 2)	Test Lenses, Then Control Lenses Participants first wore Test Lenses for 1 week (Period 1) and then wore Control Lenses for 1 week (Period 2)
Period 1 (One Week) STARTED	13	12
Period 1 (One Week) COMPLETED	13	12
Period 1 (One Week) NOT COMPLETED	0	0
Period 2 (One Week) STARTED	13	12
Period 2 (One Week) COMPLETED	13	12
Period 2 (One Week) 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 Population n=25 Participants Includes all study participants.
Age, Continuous	53.6 years STANDARD_DEVIATION 2.5 • n=25 Participants
Sex: Female, Male Female	15 Participants n=25 Participants
Sex: Female, Male Male	10 Participants n=25 Participants

PRIMARY outcome

Timeframe: One week

Overall vision satisfaction for each lens was measured on a 0-100 point Visual Analog Scale (VAS), where 0=Extremely Unsatisfied and 100=Extremely Satisfied

Outcome measures

Outcome measures
Measure	Control Lenses n=25 Participants Participants that received Control Lenses during either the first or second period of the study.	Test Lenses n=25 Participants Participants that received Test Lenses during either the first or second period of the study.
Overall Vision Satisfaction	78.6 score on a scale Standard Deviation 18.3	83.5 score on a scale Standard Deviation 14.9

PRIMARY outcome

Timeframe: Two weeks

Participants selected their preferred lens fitting approach from options - 'Control', 'Test', or 'No Preference'

Outcome measures

Outcome measures
Measure	Control Lenses n=25 Participants Participants that received Control Lenses during either the first or second period of the study.	Test Lenses Participants that received Test Lenses during either the first or second period of the study.
Overall Lens Preference Control Lenses	10 Participants	—
Overall Lens Preference Test Lenses	11 Participants	—
Overall Lens Preference No Preference	4 Participants	—

SECONDARY outcome

Timeframe: One week

Mean binocular visual performance for each lens was measured by timed logMAR charts. Overall binocular logMAR visual acuity index was calculated by taking the mean of distance and near visual acuities

Outcome measures

Outcome measures
Measure	Control Lenses n=25 Participants Participants that received Control Lenses during either the first or second period of the study.	Test Lenses n=25 Participants Participants that received Test Lenses during either the first or second period of the study.
Overall Binocular Visual Acuity Index	0.12 logMAR Standard Deviation 0.04	0.09 logMAR Standard Deviation 0.05

SECONDARY outcome

Timeframe: One week

This measured the ease of fitting each contact lens. It counted the number of contact lenses (pair), selected as per the fitting guide, used to determine the final contact lens to dispense.

Outcome measures

Outcome measures
Measure	Control Lenses n=25 Participants Participants that received Control Lenses during either the first or second period of the study.	Test Lenses n=25 Participants Participants that received Test Lenses during either the first or second period of the study.
Number of Contact Lenses	1 number of contact lenses (pair) Standard Error 0	1 number of contact lenses (pair) Standard Error 0

Adverse Events

Control Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Lenses

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

Percy Lazon de la Jara BOptom PhD

CooperVision Inc.

Phone: +1-925-251-6682

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place