Trial Outcomes & Findings for Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use (NCT NCT05166902)

NCT ID: NCT05166902

Last Updated: 2023-07-27

Results Overview

Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 67 participants
• Primary outcome timeframe: Day 27
• Results posted on: 2023-07-27

Participant Flow

Sixty-seven participants were screened with no screen failures. One participant discontinued and the remaining 66 all completed the study. All the participants who completed the study were included in the analysis. (Analysis population n=66)

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	33	34
First Intervention COMPLETED	32	34
First Intervention NOT COMPLETED	1	0
Second Intervention STARTED	32	34
Second Intervention COMPLETED	32	34
Second Intervention NOT COMPLETED	0	0

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 Lost to Follow-up	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Analysis Population n=66 Participants Sixty-six participants completed the study, and demographic data include all participants who completed the study.
Age, Categorical <=18 years	0 Participants n=66 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=66 Participants
Age, Categorical >=65 years	0 Participants n=66 Participants
Age, Continuous	27.8 Years STANDARD_DEVIATION 4.4 • n=66 Participants
Sex: Female, Male Female	51 Participants n=66 Participants
Sex: Female, Male Male	15 Participants n=66 Participants

PRIMARY outcome

Timeframe: Day 27

Population: Participants

Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult)

Outcome measures

Measure	Lens A n=66 Participants Participants wore Lens A for 1 month.	Lens B n=66 Participants Participants wore Lens B for 1 month.
Subjective Ratings on Lens Handling on Removal	8.3 Units on scale Standard Deviation 1.8	8.8 Units on scale Standard Deviation 1.2

Adverse Events

Lens A

Serious events: 0 serious events

Other events: 4 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

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	4.5% 3/66 • From dispense up to one month on each study lens, for total of two months \[Not Specified\]	1.5% 1/66 • From dispense up to one month on each study lens, for total of two months \[Not Specified\]
Product Issues Lens discomfort	1.5% 1/66 • From dispense up to one month on each study lens, for total of two months \[Not Specified\]	0.00% 0/66 • From dispense up to one month on each study lens, for total of two months \[Not Specified\]
Infections and infestations Sinus	0.00% 0/66 • From dispense up to one month on each study lens, for total of two months \[Not Specified\]	1.5% 1/66 • From dispense up to one month on each study lens, for total of two months \[Not Specified\]

Additional Information

Jose A Vega, OD, MSc, FAAO

CooperVision

Phone: 9256213761

Email: javega2@coopervision.com

Results disclosure agreements

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