Trial Outcomes & Findings for Evaluation of Marketed Soft Contact Lenses (NCT NCT05201807)

Results Overview

Overall quality of vision score 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 CLUE vision score for each lens type was reported.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

2-Week Follow-up

Results posted on

2023-03-15

Participant Flow

A total of 80 subjects were enrolled in this study. The 80 enrolled subjects met all eligibility criteria and were dispensed at least one study lens. Of those dispensed, 78 subjects completed the study while 2 subjects were discontinued.

Participant milestones

Participant milestones
Measure	DT1 (Delefilcon A) Subjects that wore the DT1 lens during the study.
Overall Study STARTED	80
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	DT1 (Delefilcon A) Subjects that wore the DT1 lens during the study.
Overall Study Adverse Event	1
Overall Study COVID-19 Related	1

Baseline Characteristics

Evaluation of Marketed Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DT1 (Delefilcon A) n=80 Participants Subjects that wore the DT1 lens during the study.
Age, Continuous	30.5 Years STANDARD_DEVIATION 5.70 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants
Race/Ethnicity, Customized White	67 Participants n=5 Participants
Region of Enrollment United States	80 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-Week Follow-up

Population: All subjects that completed all study visits without a major protocol deviation.

Overall quality of vision score 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 CLUE vision score for each lens type was reported.

Outcome measures

Outcome measures
Measure	DT1 (Delefilcon A) n=78 Participants Subjects that wore the DT1 lens during the study.
Overall Quality of Vision Score	56.9 Units on a scale Standard Deviation 25.18

PRIMARY outcome

Timeframe: 2-Week Follow-up

Population: All subjects that completed all study visits without a major protocol deviation.

Overall quality of comfort score 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 CLUE comfort score for each lens type was reported.

Outcome measures

Outcome measures
Measure	DT1 (Delefilcon A) n=78 Participants Subjects that wore the DT1 lens during the study.
Overall Quality of Comfort Score	56.3 Units on a scale Standard Deviation 29.21

Adverse Events

DT1 (Delefilcon A)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John R. Buch-Senior Principal Research Optometrist

Johnson & Johnson Vision Care, Inc.

Phone: 1-800-843-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60