Trial Outcomes & Findings for Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens (NCT NCT04849780)

Results Overview

Comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The change from baseline was calculated as 2-week follow-up minus baseline. The average change from baseline was reported for each arm. the change from baseline ranges from -120 to 120 where higher change from baseline comfort scores indicates a more favorable performance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

95 participants

Primary outcome timeframe

Up to 2-Week Follow-up

Results posted on

2022-10-10

Participant Flow

A total of 95 subjects were enrolled in this study. Of those enrolled, 47 were randomized to Arm1 and dispensed at least one study lens, while 45 subjects were randomized to Arm 2 and were dispensed at least 1 study lenses. All dispensed subjects in Arm 1 completed the study while only 39 of those dispensed in Arm 2 completed the study. A total of 6 subjects were discontinued from Arm 2.

Participant milestones

Participant milestones
Measure	Arm 2 Subjects randomized to this Arm were dispensed their habitual lenses A for approximately 2 weeks, then returned for follow-up evaluation. Subjects were then dispensed senofilcon A for approximately 2 weeks, then returned for follow-up evaluation and were exited from the study.	Arm 1 Subjects randomized to this Arm were dispensed the senofilcon A for approximately 2 weeks, then returned for follow-up evaluation and were exited from the study.
Period 1 STARTED	45	47
Period 1 COMPLETED	41	47
Period 1 NOT COMPLETED	4	0
Period 2 STARTED	41	0
Period 2 COMPLETED	39	0
Period 2 NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 2 Subjects randomized to this Arm were dispensed their habitual lenses A for approximately 2 weeks, then returned for follow-up evaluation. Subjects were then dispensed senofilcon A for approximately 2 weeks, then returned for follow-up evaluation and were exited from the study.	Arm 1 Subjects randomized to this Arm were dispensed the senofilcon A for approximately 2 weeks, then returned for follow-up evaluation and were exited from the study.
Period 1 Covid-19 Related	1	0
Period 1 Subject no longer meet eligibility criteria	3	0
Period 2 Subject no longer meet eligibility criteria	2	0

Baseline Characteristics

Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=47 Participants Subjects randomized to this Arm were dispensed the senofilcon A for approximately 2 weeks, then returned for follow-up evaluation and were exited from the study.	Arm 2 n=45 Participants Subjects randomized to this Arm were dispensed their habitual lenses A for approximately 2 weeks, then returned for follow-up evaluation. Subjects were then dispensed senofilcon A for approximately 2 weeks, then returned for follow-up evaluation and were exited from the study.	Total n=92 Participants Total of all reporting groups
Age, Continuous	34.6 years STANDARD_DEVIATION 8.14 • n=93 Participants	34.0 years STANDARD_DEVIATION 8.42 • n=4 Participants	34.3 years STANDARD_DEVIATION 8.23 • n=27 Participants
Sex: Female, Male Female	31 Participants n=93 Participants	34 Participants n=4 Participants	65 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	11 Participants n=4 Participants	27 Participants n=27 Participants
Race/Ethnicity, Customized Asian	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Race/Ethnicity, Customized White	45 participants n=93 Participants	45 participants n=4 Participants	90 participants n=27 Participants
Race/Ethnicity, Customized Other	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Region of Enrollment United States	47 participants n=93 Participants	45 participants n=4 Participants	92 participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 2-Week Follow-up

Population: Subjects that completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint.

Comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The change from baseline was calculated as 2-week follow-up minus baseline. The average change from baseline was reported for each arm. the change from baseline ranges from -120 to 120 where higher change from baseline comfort scores indicates a more favorable performance.

Outcome measures

Outcome measures
Measure	Arm 1 n=46 Participants Subjects that wore the senofilcon A lens for 2-weeks and then exited the study.	Arm 2 (Subjects' Own Contact Lens) n=39 Participants Subjects that wore their habitual lenses for 2-weeks and then wore senofilcon A for 2-weeks and then exited the study.
Change From Baseline Comfort Score	28.99 Units on a scale Standard Deviation 26.766	-0.29 Units on a scale Standard Deviation 10.245

SECONDARY outcome

Timeframe: Up to 2-Week Follow-up

Population: Subjects that completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint.

The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The change is calculated as 2-week minus Baseline. The change from baseline CLDEQ-8 score ranges from -30 to 30 where lower change from baseline CLDEQ-8 scores indicate better performance. The average change in CLDEQ-8 for each arm was reported.

Outcome measures

Outcome measures
Measure	Arm 1 n=46 Participants Subjects that wore the senofilcon A lens for 2-weeks and then exited the study.	Arm 2 (Subjects' Own Contact Lens) n=39 Participants Subjects that wore their habitual lenses for 2-weeks and then wore senofilcon A for 2-weeks and then exited the study.
Change From Baseline CLDEQ-8 Score	-10.83 Unit on a scale Standard Deviation 6.631	-1.23 Unit on a scale Standard Deviation 3.638

SECONDARY outcome

Timeframe: 2-Week Follow-up

Population: Subjects randomized to Arm 2 and completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint.

Comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average comfort score was reported for each group within Arm 2 only.

Outcome measures

Outcome measures
Measure	Arm 1 n=39 Participants Subjects that wore the senofilcon A lens for 2-weeks and then exited the study.	Arm 2 (Subjects' Own Contact Lens) n=39 Participants Subjects that wore their habitual lenses for 2-weeks and then wore senofilcon A for 2-weeks and then exited the study.
Comfort Score	55.88 Unit on a scale Standard Deviation 25.721	29.69 Unit on a scale Standard Deviation 13.849

SECONDARY outcome

Timeframe: 2-Week Follow-up

Population: Subjects randomized to Arm 2 and completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint.

The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The average CLDEQ-8 for each arm was reported.