Trial Outcomes & Findings for Evaluation of the Performance of Monthly Replacement Sphere Lens Designs in Habitual Soft Contact Lens Wearers (NCT NCT05114564)

Results Overview

Subjective Ratings on Lens handling on removal (0-10 scale, 0.5 steps; 10=very easy, 0=very difficult)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

Day 27

Results posted on

2023-04-04

Participant Flow

Sixty-six participants were screened. Of the 66 that were dispensed with lenses, two were discontinued. One of the completing participants presented at the final visit wearing an unknown lens. It was decided to exclude all the data for this participant and this finding was reported as a major protocol deviation. All remaining participants who completed the study were included in the analysis (Analysis population n=63).

Participant milestones

Participant milestones
Measure	Lens B, Then Lens A Participants wore Lens B for one month and then crossed over to wear Lens A for one month.	Lens A, Then Lens B Participants wore Lens A for one month and then crossed over to wear Lens B for one month.
First Intervention STARTED	34	32
First Intervention COMPLETED	33	31
First Intervention NOT COMPLETED	1	1
Second Intervention STARTED	33	31
Second Intervention COMPLETED	33	31
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lens B, Then Lens A Participants wore Lens B for one month and then crossed over to wear Lens A for one month.	Lens A, Then Lens B Participants wore Lens A for one month and then crossed over to wear Lens B for one month.
First Intervention Vision with study contact lens subjectively unacceptable	1	0
First Intervention Adverse Event	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=66 Participants Total study population
Age, Continuous	27.5 years STANDARD_DEVIATION 4.8 • n=66 Participants
Sex: Female, Male Female	46 Participants n=66 Participants
Sex: Female, Male Male	20 Participants n=66 Participants

PRIMARY outcome

Timeframe: Day 27

Subjective Ratings on Lens handling on removal (0-10 scale, 0.5 steps; 10=very easy, 0=very difficult)

Outcome measures

Outcome measures
Measure	Lens A n=63 Participants Participants wore Lens A for one month.	Lens B n=63 Participants Participants wore Lens B for one month.
Subjective Ratings on Lens Handling on Removal	8.6 units on a scale Standard Deviation 1.6	8.5 units on a scale Standard Deviation 2.2

Adverse Events

Lens A

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Lens B

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lens A n=66 participants at risk Participants wore Lens A for one month.	Lens B n=66 participants at risk Participants wore Lens B for one month.
Social circumstances COVID-19	3.0% 2/66 • From dispense up to one month on each study lens, for a total of two months	1.5% 1/66 • From dispense up to one month on each study lens, for a total of two months
Infections and infestations Sinus infection	0.00% 0/66 • From dispense up to one month on each study lens, for a total of two months	1.5% 1/66 • From dispense up to one month on each study lens, for a total of two months
Eye disorders Single infiltrate in superior cornea	1.5% 1/66 • From dispense up to one month on each study lens, for a total of two months	0.00% 0/66 • From dispense up to one month on each study lens, for a total of two months

Additional Information

José A. Vega, O.D., MSc., FAAO

CooperVision

Phone: 925-621-3761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place