Trial Outcomes & Findings for Contact Lenses With New UV-blocker Manufactured With Different Techniques (NCT NCT03475875)

Last Updated: 2019-06-04

Results Overview

Overall 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. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

92 participants

Primary outcome timeframe

2- Week Follow-up Evaluation

Results posted on

2019-06-04

Participant Flow

A total of 92 subjects were enrolled into this study. Of those enrolled, 91 were dispensed a study lens and 1 subject failed to meet the eligibility criteria. Of the dispensed subjects 83 completed the study while 8 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Test/Control/Control Subjects that wore the Test lens during the first period, the Control lens during the second period and the Control lens again in the third period.	Control/Test/Test Subjects that wore the Control lens during the first period, the Test lens during the second period and the Test lens again in the third period.
Period 1 STARTED	46	45
Period 1 COMPLETED	43	44
Period 1 NOT COMPLETED	3	1
Period 2 STARTED	43	44
Period 2 COMPLETED	40	43
Period 2 NOT COMPLETED	3	1
Period 3 STARTED	40	43
Period 3 COMPLETED	40	43
Period 3 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Test/Control/Control Subjects that wore the Test lens during the first period, the Control lens during the second period and the Control lens again in the third period.	Control/Test/Test Subjects that wore the Control lens during the first period, the Test lens during the second period and the Test lens again in the third period.
Period 1 Lost to Follow-up	1	0
Period 1 Adverse Event	2	1
Period 2 Adverse Event	3	0
Period 2 Protocol Violation	0	1

Baseline Characteristics

Contact Lenses With New UV-blocker Manufactured With Different Techniques

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=91 Participants All subjects dispensed at least one study lens.
Age, Continuous	31.8 Years STANDARD_DEVIATION 6.32 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Native Alaska	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	11 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized White	69 Participants n=5 Participants
Race/Ethnicity, Customized Other	7 Participants n=5 Participants
Region of Enrollment United States	91 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2- Week Follow-up Evaluation

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

Outcome measures

Outcome measures
Measure	Test n=78 Participants Subjects that wore the Test lens during any of the three study periods.	Control n=78 Participants Subjects that wore the Control lens during any of the three study periods.
Overall Comfort Score	61.49 Units on a scale Standard Deviation 21.087	67.27 Units on a scale Standard Deviation 22.865

PRIMARY outcome

Timeframe: 2- Week Follow-up Evaluation

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

Overall vision 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. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.

Outcome measures

Outcome measures
Measure	Test n=78 Participants Subjects that wore the Test lens during any of the three study periods.	Control n=78 Participants Subjects that wore the Control lens during any of the three study periods.
Overall Vision Score	61.79 Units on a scale Standard Deviation 17.758	64.92 Units on a scale Standard Deviation 17.444

Adverse Events

Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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 Buch - Senior Principal Research Optometrist

Johnson & Johnson Vision

Phone: 904-443-1707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60