Trial Outcomes & Findings for Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens (NCT NCT06328660)

Results Overview

The ease of contact lens insertion and removal over the week preceding the follow-up visit measured on a 100-point visual analog scale, where 0=Very difficult, Painful and 100=Very easy, Can't feel the lenses

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

1 week

Results posted on

2025-07-28

Participant Flow

A total of 67 potential participants were screened, one participant did not fulfil the entry criteria (prescription out of range).

Participant milestones

Participant milestones
Measure	Frequent Replacement Silicone Hydrogel Contact Lens (Lens 1) All participants wore Lens 1 for 14 ± 3 days (Period 1)	Daily Disposable Silicone Hydrogel Contact Lens (Lens 2) All participants wore Lens 2 for 14 ± 3 days (Period 2)
Lens 1, 14 ± 3 Days STARTED	66	0
Lens 1, 14 ± 3 Days COMPLETED	66	0
Lens 1, 14 ± 3 Days NOT COMPLETED	0	0
Lens 2, 14 ± 3 Days STARTED	0	66
Lens 2, 14 ± 3 Days COMPLETED	0	66
Lens 2, 14 ± 3 Days 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	All Study Participants n=66 Participants Includes study participants that completed all study visits
Age, Continuous	53.9 years STANDARD_DEVIATION 6.7 • n=66 Participants
Sex: Female, Male Female	52 Participants n=66 Participants
Sex: Female, Male Male	14 Participants n=66 Participants

PRIMARY outcome

Timeframe: 1 week

The ease of contact lens insertion and removal over the week preceding the follow-up visit measured on a 100-point visual analog scale, where 0=Very difficult, Painful and 100=Very easy, Can't feel the lenses

Outcome measures

Outcome measures
Measure	Lens 1 n=66 Participants Participants that received Lens 1	Lens 2 n=66 Participants Participants that received Lens 2
Overall Lens Handling	96.0 score on a scale Standard Deviation 15.5	90.0 score on a scale Standard Deviation 21.0

SECONDARY outcome

Timeframe: 14 days

The mean logMAR visual acuity of the dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.

Outcome measures

Outcome measures
Measure	Lens 1 n=66 Participants Participants that received Lens 1	Lens 2 n=66 Participants Participants that received Lens 2
Overall logMAR Visual Acuity - Dominant Eye	0.01 logMAR Standard Deviation 0.09	0.01 logMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: 14 days

The mean logMAR visual acuity of the non-dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.

Outcome measures

Outcome measures
Measure	Lens 1 n=66 Participants Participants that received Lens 1	Lens 2 n=66 Participants Participants that received Lens 2
Overall logMAR Visual Acuity - Non-Dominant Eye	0.01 logMAR Standard Deviation 0.07	0.00 logMAR Standard Deviation 0.08

SECONDARY outcome

Timeframe: 14 days

The mean binocular logMAR visual acuity calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.

Outcome measures

Outcome measures
Measure	Lens 1 n=66 Participants Participants that received Lens 1	Lens 2 n=66 Participants Participants that received Lens 2
Overall logMAR Visual Acuity - Binocular	-0.05 logMAR Standard Deviation 0.07	-0.05 logMAR Standard Deviation 0.07

Adverse Events

Lens 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Lens 2

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lens 1 n=66 participants at risk Participants that received Lens 1	Lens 2 n=66 participants at risk Participants that received Lens 2
Respiratory, thoracic and mediastinal disorders Pharyngitis	1.5% 1/66 • Number of events 1 • Duration of the study, approximately 1 month	0.00% 0/66 • Duration of the study, approximately 1 month
Nervous system disorders Dizziness	1.5% 1/66 • Number of events 1 • Duration of the study, approximately 1 month	0.00% 0/66 • Duration of the study, approximately 1 month
Respiratory, thoracic and mediastinal disorders Flu	3.0% 2/66 • Number of events 2 • Duration of the study, approximately 1 month	1.5% 1/66 • Number of events 1 • Duration of the study, approximately 1 month
Eye disorders Itchy Eye	0.00% 0/66 • Duration of the study, approximately 1 month	1.5% 1/66 • Number of events 1 • Duration of the study, approximately 1 month
Nervous system disorders Headache	0.00% 0/66 • Duration of the study, approximately 1 month	3.0% 2/66 • Number of events 2 • Duration of the study, approximately 1 month
Respiratory, thoracic and mediastinal disorders Common Cold	0.00% 0/66 • Duration of the study, approximately 1 month	3.0% 2/66 • Number of events 2 • Duration of the study, approximately 1 month

Additional Information

José A. Vega

CooperVision Inc.

Phone: +1 (925) 621-3761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place