Trial Outcomes & Findings for Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses (NCT NCT04968925)

Results Overview

Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

302 participants

Primary outcome timeframe

1-Week Follow-up

Results posted on

2022-12-22

Participant Flow

This was a 2-Phase study. In Phase I, 75 subjects were enrolled. Of those enrolled into Phase I, all subjects were dispensed at least 1 study lens. Of those dispensed, 72 completed Phase I, while 3 subject discontinued. In Phase II, 227 subjects were enrolled. Of those enrolled, all subjects were dispensed at least 1 study lens. Of those dispensed in Phase II 206 completed the Phase II, while 21 subjects discontinued from Phase II.

Phase I and Phase II are mutually exclusive. Data collected from Phase I was used to estimate the sample size requirements for Phase II primary endpoints.

Participant milestones

Participant milestones
Measure	Senofilcon A (C3)/Verofilcon A (Phase I) Subjects randomized to this sequence received the senofilcon A (C3) lens during the first period and then received the verofilcon A lens during the second period.	Verofilcon A/ Senofilcon A (C3) (Phase I) verofilcon A/ senofilcon A (C3) (Phase I) Subjects randomized to this sequence received the verofilcon A lens during the first period and then received the senofilcon A (C3) lens during the second period.	Senofilcon A (C3)/Verofilcon A (Phase II) Subjects randomized to this sequence received the senofilcon A (C3) lens during the first period and then received the verofilcon A lens during the second period.	Verofilcon A/ Senofilcon A (C3) (Phase II) Subjects randomized to this sequence received the verofilcon A lens during the first period and then received the senofilcon A (C3) lens during the second period.
Phase I- Period 1 STARTED	35	40	0	0
Phase I- Period 1 COMPLETED	34	38	0	0
Phase I- Period 1 NOT COMPLETED	1	2	0	0
Phase I- Period 2 STARTED	34	38	0	0
Phase I- Period 2 COMPLETED	34	38	0	0
Phase I- Period 2 NOT COMPLETED	0	0	0	0
Phase II- Period 1 STARTED	0	0	112	115
Phase II- Period 1 COMPLETED	0	0	105	109
Phase II- Period 1 NOT COMPLETED	0	0	7	6
Phase II -Period 2 STARTED	0	0	105	109
Phase II -Period 2 COMPLETED	0	0	101	105
Phase II -Period 2 NOT COMPLETED	0	0	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon A (C3)/Verofilcon A (Phase I) Subjects randomized to this sequence received the senofilcon A (C3) lens during the first period and then received the verofilcon A lens during the second period.	Verofilcon A/ Senofilcon A (C3) (Phase I) verofilcon A/ senofilcon A (C3) (Phase I) Subjects randomized to this sequence received the verofilcon A lens during the first period and then received the senofilcon A (C3) lens during the second period.	Senofilcon A (C3)/Verofilcon A (Phase II) Subjects randomized to this sequence received the senofilcon A (C3) lens during the first period and then received the verofilcon A lens during the second period.	Verofilcon A/ Senofilcon A (C3) (Phase II) Subjects randomized to this sequence received the verofilcon A lens during the first period and then received the senofilcon A (C3) lens during the second period.
Phase I- Period 1 COVID-19 related	0	1	0	0
Phase I- Period 1 Subject enrolled in error	1	1	0	0
Phase II- Period 1 COVID-19 Related	0	0	6	6
Phase II- Period 1 Subject enrolled in error	0	0	1	0
Phase II -Period 2 COVID-19 related	0	0	4	3
Phase II -Period 2 Incorrectly dispensed	0	0	0	1

Baseline Characteristics

Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I n=75 Participants All subjects that were enrolled into Phase I of the study.	Phase II n=227 Participants All subjects that were enrolled in Phase II of the study	Total n=302 Participants Total of all reporting groups
Age, Continuous	28.4 Years STANDARD_DEVIATION 6.94 • n=5 Participants	29.4 Years STANDARD_DEVIATION 6.23 • n=7 Participants	29.2 Years STANDARD_DEVIATION 6.42 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	172 Participants n=7 Participants	222 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	55 Participants n=7 Participants	80 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants	24 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	63 Participants n=5 Participants	191 Participants n=7 Participants	254 Participants n=5 Participants
Region of Enrollment United States	75 Participants n=5 Participants	227 Participants n=7 Participants	302 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All Subjects that completed Phase I of the study without a major protocol deviation impacting a primary endpoint.

Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Outcome measures

Outcome measures
Measure	Senofilcon A (C3) n=72 Participants Subjects that wore the senofilcon A (C3) lens in either the first or second period of Phase I study.	Verofilcon A n=72 Participants Subjects that wore the verofilcon A lens in either the first or second period of Phase I study.
Overall Comfort (Phase I) Excellent	45 Number of responses	32 Number of responses
Overall Comfort (Phase I) Very Good	20 Number of responses	23 Number of responses
Overall Comfort (Phase I) Good	5 Number of responses	9 Number of responses
Overall Comfort (Phase I) Fair	2 Number of responses	7 Number of responses
Overall Comfort (Phase I) Poor	0 Number of responses	1 Number of responses

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All Subjects that completed Phase I of the study without a major protocol deviation impacting a primary endpoint.

End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with aa 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Outcome measures

Outcome measures
Measure	Senofilcon A (C3) n=72 Participants Subjects that wore the senofilcon A (C3) lens in either the first or second period of Phase I study.	Verofilcon A n=72 Participants Subjects that wore the verofilcon A lens in either the first or second period of Phase I study.
End of Day Comfort (Phase I) Excellent	29 Number of responses	25 Number of responses
End of Day Comfort (Phase I) Very Good	28 Number of responses	17 Number of responses
End of Day Comfort (Phase I) Good	9 Number of responses	16 Number of responses
End of Day Comfort (Phase I) Fair	4 Number of responses	10 Number of responses
End of Day Comfort (Phase I) Poor	2 Number of responses	4 Number of responses

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All Subjects that completed Phase I of the study without a major protocol deviation impacting a primary endpoint.

End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.