Trial Outcomes & Findings for Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses (NCT NCT05763628)

NCT ID: NCT05763628

Last Updated: 2024-07-08

Results Overview

Subjective rating for ease of removal of the study lenses on a 0-100 scale, where 0=Very difficult and 100=Very easy. Collected once at the end of 2 weeks of wear.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 59 participants
• Primary outcome timeframe: 2 Weeks
• Results posted on: 2024-07-08

Participant Flow

Of the 60 participants screened, 1 exited the study prior to randomization due to screen failure.

Participant milestones

Measure	Control Lens, Then Test Lens Participants first wore Control Lens for 2 weeks, then crossed over to wear Test Lens for 2 weeks	Test Lens, Then Control Lens Participants first wore Test Lens for 2 weeks, then crossed over to wear Control Lens for 2 weeks
Period 1: First Intervention, 2 Weeks STARTED	29	30
Period 1: First Intervention, 2 Weeks COMPLETED	29	28
Period 1: First Intervention, 2 Weeks NOT COMPLETED	0	2
Period 2: Second Intervention, 2 Weeks STARTED	29	28
Period 2: Second Intervention, 2 Weeks COMPLETED	28	28
Period 2: Second Intervention, 2 Weeks NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Control Lens, Then Test Lens Participants first wore Control Lens for 2 weeks, then crossed over to wear Test Lens for 2 weeks	Test Lens, Then Control Lens Participants first wore Test Lens for 2 weeks, then crossed over to wear Control Lens for 2 weeks
Period 1: First Intervention, 2 Weeks Protocol Violation	0	1
Period 1: First Intervention, 2 Weeks Withdrawal by Subject	0	1
Period 2: Second Intervention, 2 Weeks Protocol Violation	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Total Study Population n=60 Participants All participants that attended one or more study visits
Age, Continuous	53.3 years STANDARD_DEVIATION 6.5 • n=60 Participants
Sex: Female, Male Female	47 Participants n=60 Participants
Sex: Female, Male Male	13 Participants n=60 Participants

PRIMARY outcome

Timeframe: 2 Weeks

Population: Participants that completed all study visits.

Subjective rating for ease of removal of the study lenses on a 0-100 scale, where 0=Very difficult and 100=Very easy. Collected once at the end of 2 weeks of wear.

Outcome measures

Measure	Control Lens n=56 Participants Participants that received the Control Lens during either the first or second period of the study	Test Lens n=56 Participants Participants that received the Test Lens during either the first or second period of the study
Lens Handling for Removal	94 score on a scale Standard Deviation 10	95 score on a scale Standard Deviation 10

Adverse Events

Control Lens

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Test Lens

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control Lens n=57 participants at risk Participants that received the Control Lens during either the first or second period of the study	Test Lens n=58 participants at risk Participants that received the Test Lens during either the first or second period of the study
Eye disorders Stye	0.00% 0/57 • Duration of the study, approximately 6 weeks (prescription optimization for 3-8 days, then test lens wear for 2 weeks each)	1.7% 1/58 • Number of events 1 • Duration of the study, approximately 6 weeks (prescription optimization for 3-8 days, then test lens wear for 2 weeks each)
Eye disorders Eyelid myokymia	1.8% 1/57 • Number of events 1 • Duration of the study, approximately 6 weeks (prescription optimization for 3-8 days, then test lens wear for 2 weeks each)	0.00% 0/58 • Duration of the study, approximately 6 weeks (prescription optimization for 3-8 days, then test lens wear for 2 weeks each)
Surgical and medical procedures Dose increase	0.00% 0/57 • Duration of the study, approximately 6 weeks (prescription optimization for 3-8 days, then test lens wear for 2 weeks each)	1.7% 1/58 • Number of events 1 • Duration of the study, approximately 6 weeks (prescription optimization for 3-8 days, then test lens wear for 2 weeks each)
Surgical and medical procedures Botox Injection Forehead	0.00% 0/57 • Duration of the study, approximately 6 weeks (prescription optimization for 3-8 days, then test lens wear for 2 weeks each)	1.7% 1/58 • Number of events 1 • Duration of the study, approximately 6 weeks (prescription optimization for 3-8 days, then test lens wear for 2 weeks each)
Nervous system disorders Vertigo	1.8% 1/57 • Number of events 1 • Duration of the study, approximately 6 weeks (prescription optimization for 3-8 days, then test lens wear for 2 weeks each)	0.00% 0/58 • Duration of the study, approximately 6 weeks (prescription optimization for 3-8 days, then test lens wear for 2 weeks each)

Additional Information

José A. Vega OD, PhD, MSc, FAAO

CooperVision Inc.

Phone: +19256213761

Email: jvega2@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place