Trial Outcomes & Findings for Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY (NCT NCT01467557)

Results Overview

Adverse events were reported by subjects via the electronic surveys if they responded "yes" to the question "Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?". Consensus diagnosis was made after review of clinical records by Adjudication Panel.

Recruitment status

COMPLETED

Target enrollment

1171 participants

Primary outcome timeframe

Self-report at 2 Week, 4 Month or 12 Month surveys

Results posted on

2018-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	1-Day ACUVUE TruEye Contact Lens Users 1-Day ACUVUE TruEye contact lens users narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses	1-Day ACUVUE MOIST Contact Lens Users 1-Day ACUVUE MOIST contact lens users etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses
Overall Study STARTED	601	570
Overall Study 2 Week Survey Completed	551	522
Overall Study 4 Month Survey Completed	533	493
Overall Study 12 Month Survey Completed	502	463
Overall Study COMPLETED	502	463
Overall Study NOT COMPLETED	99	107

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1-Day ACUVUE TruEye Contact Lens Users n=601 Participants 1-Day ACUVUE TruEye contact lens users narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses	1-Day ACUVUE MOIST Contact Lens Users n=570 Participants 1-Day ACUVUE MOIST contact lens users etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses	Total n=1171 Participants Total of all reporting groups
Age, Categorical <=18 years	106 Participants n=99 Participants	121 Participants n=107 Participants	227 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	484 Participants n=99 Participants	445 Participants n=107 Participants	929 Participants n=206 Participants
Age, Categorical >=65 years	11 Participants n=99 Participants	4 Participants n=107 Participants	15 Participants n=206 Participants
Age, Continuous	33.2 years STANDARD_DEVIATION 13.9 • n=99 Participants	30.3 years STANDARD_DEVIATION 12.9 • n=107 Participants	31.8 years STANDARD_DEVIATION 13.5 • n=206 Participants
Sex: Female, Male Female	400 Participants n=99 Participants	392 Participants n=107 Participants	792 Participants n=206 Participants
Sex: Female, Male Male	201 Participants n=99 Participants	178 Participants n=107 Participants	379 Participants n=206 Participants
Region of Enrollment United States	601 participants n=99 Participants	570 participants n=107 Participants	1171 participants n=206 Participants

PRIMARY outcome

Timeframe: Self-report at 2 Week, 4 Month or 12 Month surveys

Population: The analysis population consisted of subjects that were enrolled into this study. (i.e subjects that met all study eligibility criteria)

Adverse events were reported by subjects via the electronic surveys if they responded "yes" to the question "Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?". Consensus diagnosis was made after review of clinical records by Adjudication Panel.

Outcome measures

Outcome measures
Measure	1-Day ACUVUE TruEye Contact Lens Users n=601 Participants 1-Day ACUVUE TruEye contact lens users narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses. Registered Wearers who had been recently fit with these daily disposable lenses.	1-Day ACUVUE MOIST Contact Lens Users n=570 Participants 1-Day ACUVUE MOIST contact lens users etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses. Registered Wearers who had been recently fit with these daily disposable lenses.
Incidence of Adverse Events Corneal Infiltrative Events	2 participants	0 participants
Incidence of Adverse Events CL-Related Adverse Events with Office Visit	8 participants	3 participants
Incidence of Adverse Events Not CL-Related Adverse Events with Office Visit	5 participants	2 participants
Incidence of Adverse Events "Yes" to Red Eye Question, but no Office Visit	6 participants	5 participants

SECONDARY outcome

Timeframe: Baseline, 2 Week, 4 Month or 12 Month surveys

Population: The analysis population consists of all subjects that were considered to be experienced contact lens wearers. Subjects were considered to be experienced contact lens wearers if subjects were assigned daily disposable lens at all evaluation points.

The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous).

Outcome measures

Outcome measures
Measure	1-Day ACUVUE TruEye Contact Lens Users n=418 Participants 1-Day ACUVUE TruEye contact lens users narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses. Registered Wearers who had been recently fit with these daily disposable lenses.	1-Day ACUVUE MOIST Contact Lens Users n=400 Participants 1-Day ACUVUE MOIST contact lens users etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses. Registered Wearers who had been recently fit with these daily disposable lenses.
Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys Baseline, n=368, 320	12.8 units on a scale Standard Deviation 7.2	12.3 units on a scale Standard Deviation 7.2
Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys 2 weeks, n=418,400	7.3 units on a scale Standard Deviation 5.2	8.0 units on a scale Standard Deviation 5.5
Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys 4 months, n=418,400	8.7 units on a scale Standard Deviation 5.7	9.3 units on a scale Standard Deviation 6.2
Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys 12 months, n=418,400	9.0 units on a scale Standard Deviation 6.3	9.2 units on a scale Standard Deviation 6.1

Adverse Events

1-Day ACUVUE TruEye Contact Lens Users

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1-Day ACUVUE MOIST Contact Lens Users

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

Jurandir Araujo

Vistakon

Phone: +1 904 443-1379

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60