Trial Outcomes & Findings for Clinical Evaluation of Reusable Soft Contact Lenses (NCT NCT06119191)

Results Overview

Monocular distance logMAR visual acuity at distance 4 meters under high illumination, high contrast conditions was measured at the 4 week timepoint of lens wear.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

77 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-04-08

Participant Flow

Three participants did not meet the inclusion criteria and were excluded from the analysis.

Participant milestones

Participant milestones
Measure	Control Lenses Participants wore Control Lenses for 30±2 days	Test Lenses Participants wore Test Lenses for 30±2 days
Overall Study STARTED	26	48
Overall Study COMPLETED	25	47
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Lenses Participants wore Control Lenses for 30±2 days	Test Lenses Participants wore Test Lenses for 30±2 days
Overall Study Adverse Event	0	1
Overall Study Protocol Violation	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Lenses n=25 Participants Participants that received the Control Lens	Test Lenses n=47 Participants Participants that received the Test Lens	Total n=72 Participants Total of all reporting groups
Age, Continuous	30.6 years STANDARD_DEVIATION 11.0 • n=25 Participants	29.0 years STANDARD_DEVIATION 8.5 • n=47 Participants	29.5 years STANDARD_DEVIATION 9.4 • n=72 Participants
Sex: Female, Male Female	21 Participants n=25 Participants	29 Participants n=47 Participants	50 Participants n=72 Participants
Sex: Female, Male Male	4 Participants n=25 Participants	18 Participants n=47 Participants	22 Participants n=72 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 4 weeks

Population: Analysis population includes all participants that were eligible (inclusion/exclusion criteria) and completed all study visits.

Monocular distance logMAR visual acuity at distance 4 meters under high illumination, high contrast conditions was measured at the 4 week timepoint of lens wear.

Outcome measures

Outcome measures
Measure	Control Lenses n=25 Participants Participants that received the Control Lens	Test Lenses n=47 Participants Participants that received the Test Lens
Visual Acuity	-0.07 logMAR Standard Deviation 0.08	-0.13 logMAR Standard Deviation 0.08

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: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control Lenses n=26 participants at risk Participants that received the Control Lens	Test Lenses n=48 participants at risk Participants that received the Test Lens
Eye disorders Ocular Hyperemia and Discomfort	0.00% 0/26 • Length of study, approximately 30±2 days	2.1% 1/48 • Number of events 1 • Length of study, approximately 30±2 days

Additional Information

Cameron Postnikoff

CooperVision, Inc.

Phone: 925-730-6734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place