Trial Outcomes & Findings for Evaluation of Three Daily Disposable Contact Lenses (NCT NCT02568254)

Last Updated: 2017-07-17

Results Overview

Clue 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

78 participants

Primary outcome timeframe

2- Week Follow-up

Results posted on

2017-07-17

Participant Flow

A total of 78 subjects were enrolled in this study. Of the enrolled subjects 74 subjects were dispensed at least 1 study lens and 4 subjects did not meet the eligbility criteria. Of the dispensed subjects 72 completed the study and 2 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Etafilcon A/ Nelfilcon A/ Nesofilcon A All subjects that were randomized to receive the etafilcon A lens first, the nelfilcon A lens second and the nesofilcon A lens third.	Etafilcon A/ Nesofilcon A/ Nelfilcon A All subjects that were randomized to receive the etafilcon A lens first, the nesofilcon A lens second and the nelfilcon A lens third.	Nelfilcon A/ Nesofilcon A/ Etafilcon A All subjects that were randomized to receive the nelfilcon A lens first, the nesofilcon A lens second and the etafilcon A lens third.	Nelfilcon A/ Etafilcon A/ Nesofilcon A All subjects that were randomzied to receive the nelfilcon A lens first, the etafilcon A lens second and the nesofilcon A lens third.	Nesolfilcon A/ Etafilcon A/ Nelfilcon A All subjects that were randomized to receive the nesofilcon A lens first, the etafilcon A lens second and the nelfilcon A lens third.	Nesofilcon A/ Nelfilcon A/Etafilcon A All subjects that were randomized to receive the nesofilcon A lens first, the nelfilcon A lens second and the etafilcon A lens third.
Period 1 STARTED	13	12	13	12	12	12
Period 1 COMPLETED	13	12	13	12	12	12
Period 1 NOT COMPLETED	0	0	0	0	0	0
Period 2 STARTED	13	12	13	12	12	12
Period 2 COMPLETED	13	12	12	12	12	12
Period 2 NOT COMPLETED	0	0	1	0	0	0
Period 3 STARTED	13	12	12	12	12	12
Period 3 COMPLETED	13	12	12	12	11	12
Period 3 NOT COMPLETED	0	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Etafilcon A/ Nelfilcon A/ Nesofilcon A All subjects that were randomized to receive the etafilcon A lens first, the nelfilcon A lens second and the nesofilcon A lens third.	Etafilcon A/ Nesofilcon A/ Nelfilcon A All subjects that were randomized to receive the etafilcon A lens first, the nesofilcon A lens second and the nelfilcon A lens third.	Nelfilcon A/ Nesofilcon A/ Etafilcon A All subjects that were randomized to receive the nelfilcon A lens first, the nesofilcon A lens second and the etafilcon A lens third.	Nelfilcon A/ Etafilcon A/ Nesofilcon A All subjects that were randomzied to receive the nelfilcon A lens first, the etafilcon A lens second and the nesofilcon A lens third.	Nesolfilcon A/ Etafilcon A/ Nelfilcon A All subjects that were randomized to receive the nesofilcon A lens first, the etafilcon A lens second and the nelfilcon A lens third.	Nesofilcon A/ Nelfilcon A/Etafilcon A All subjects that were randomized to receive the nesofilcon A lens first, the nelfilcon A lens second and the etafilcon A lens third.
Period 2 Adverse Event	0	0	1	0	0	0
Period 3 Unstatisfactory Lens fitting	0	0	0	0	1	0

Baseline Characteristics

Evaluation of Three Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=74 Participants All subjects that were dispensed at least 1 study lens.
Age, Continuous	24.3 Years STANDARD_DEVIATION 5.71 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	25 Participants n=5 Participants
Race/Ethnicity, Customized White	45 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants
Region of Enrollment North America	74 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2- Week Follow-up

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

Outcome measures

Outcome measures
Measure	Etafilcon A n=72 Participants All subjects that wore the etafilcon A lens during any one of the 3 periods in the study.	Nelfilcon A n=72 Participants All subjects that wore the nelfilcon A lens in any of the 3 periods of the study.	Nesofilcon A n=72 Participants All subjects that wore the nesofilcon A lens in any of the 3 periods in the study.
Overall Comfort	58.74 Units on a scale Standard Deviation 25.350	48.14 Units on a scale Standard Deviation 25.166	57.32 Units on a scale Standard Deviation 25.84

Adverse Events

Etafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nelfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nesofilcon 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

Chantal Coles-Brennan BSc, OD, FAAOPrincipal Research Optometrist

Johnson & Johnson Vision Care Inc.

Phone: 904 443 3449

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60