Trial Outcomes & Findings for Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers (NCT NCT06098339)

NCT ID: NCT06098339

Last Updated: 2024-08-28

Results Overview

Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: Day 27
• Results posted on: 2024-08-28

Participant Flow

Participant milestones

Measure	Lens A, Then Lens B Participants wore Lens A for one month and then Lens B for one month.	Lens B, Then Lens A Participants wore Lens B for one month and then Lens A for one month.
Period 1: First Intervention 28-32 Days STARTED	25	28
Period 1: First Intervention 28-32 Days COMPLETED	24	26
Period 1: First Intervention 28-32 Days NOT COMPLETED	1	2
Period 2: Second Intervention 28-32 Days STARTED	24	26
Period 2: Second Intervention 28-32 Days COMPLETED	24	26
Period 2: Second Intervention 28-32 Days NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Lens A, Then Lens B Participants wore Lens A for one month and then Lens B for one month.	Lens B, Then Lens A Participants wore Lens B for one month and then Lens A for one month.
Period 1: First Intervention 28-32 Days Lost to Follow-up	0	1
Period 1: First Intervention 28-32 Days Enrolled outside the study inclusion/exclusion criteria and was discontinued early	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Total Study Population n=53 Participants All participants that were dispensed intervention (Lens A or Lens B), regardless of eligibility or study completion
Age, Continuous	28.2 years STANDARD_DEVIATION 6.0 • n=53 Participants
Sex: Female, Male Female	37 Participants n=53 Participants
Sex: Female, Male Male	16 Participants n=53 Participants

PRIMARY outcome

Timeframe: Day 27

Population: Analysis population includes all participants that were eligible (inclusion/exclusion criteria) and completed all study visits. Of 50 participants that completed the study, 1 was removed from the analysis due to a symptomatic adverse event at the final study visit which may have impacted the study data.

Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.

Outcome measures

Measure	Lens A n=49 Participants Participants that received Lens A during either the first or second period of the study	Lens B n=49 Participants Participants that received Lens B during either the first or second period of the study
Lens Handling on Removal	84 score on a scale Standard Deviation 21	89 score on a scale Standard Deviation 17

Adverse Events

Lens A

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Lens B

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lens A n=50 participants at risk Participants that received Lens A	Lens B n=50 participants at risk Participants that received Lens B
Eye disorders Asymptomatic corneal infiltrate event	2.0% 1/50 • Number of events 1 • The duration of the clinical trial, approximately 2-3 months	2.0% 1/50 • Number of events 1 • The duration of the clinical trial, approximately 2-3 months
Eye disorders Lower lid small chalazion	0.00% 0/50 • The duration of the clinical trial, approximately 2-3 months	2.0% 1/50 • Number of events 1 • The duration of the clinical trial, approximately 2-3 months
Eye disorders Nasal upper lid papilloma	0.00% 0/50 • The duration of the clinical trial, approximately 2-3 months	2.0% 1/50 • Number of events 1 • The duration of the clinical trial, approximately 2-3 months
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	2.0% 1/50 • Number of events 1 • The duration of the clinical trial, approximately 2-3 months	0.00% 0/50 • The duration of the clinical trial, approximately 2-3 months
Eye disorders Viral conjunctivitis	0.00% 0/50 • The duration of the clinical trial, approximately 2-3 months	2.0% 1/50 • Number of events 2 • The duration of the clinical trial, approximately 2-3 months
Eye disorders Ocular discomfort,	6.0% 3/50 • Number of events 5 • The duration of the clinical trial, approximately 2-3 months	0.00% 0/50 • The duration of the clinical trial, approximately 2-3 months

Additional Information

José A. Vega, O.D., MSc., PhD, FAAO

CooperVision Inc.

Phone: 925-621-3761

Email: JVega2@coopervision.com

Results disclosure agreements

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