Trial Outcomes & Findings for Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens (NCT NCT01484054)

Results Overview

The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores 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 from 0-120.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

103 participants

Primary outcome timeframe

After 7 to 9 days of lens wear

Results posted on

2018-06-19

Participant Flow

Of those 103 enrolled subjects, 3 subjects did not receive the study article.

Participant milestones

Participant milestones
Measure	EAPVPDE/EADE etafilcon A with embedded print and PVP for dark eyes lens worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.	EADE/EAPVPDE etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.
Period 1 STARTED	50	50
Period 1 COMPLETED	50	49
Period 1 NOT COMPLETED	0	1
Period 2 STARTED	50	49
Period 2 COMPLETED	50	49
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	EAPVPDE/EADE etafilcon A with embedded print and PVP for dark eyes lens worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.	EADE/EAPVPDE etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.
Period 1 Withdrawal by Subject	0	1

Baseline Characteristics

Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=100 Participants All enrolled subjects who received study lenses.
Age, Continuous	25.07 years STANDARD_DEVIATION 4.879 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants

PRIMARY outcome

Timeframe: After 7 to 9 days of lens wear

Population: Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.

The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores 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 from 0-120.

Outcome measures

Outcome measures
Measure	EAPVPDE n=92 Participants A daily disposable contact lens.	EADE n=92 Participants A marketed daily disposable contact lens
Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire	54.06 units on a scale Standard Error 2.538 • Interval 48.56 to 59.57	53.06 units on a scale Standard Error 2.537 • Interval 47.56 to 58.57

PRIMARY outcome

Timeframe: After 7 to 9 days of lens wear

Population: Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.

The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores 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.

Outcome measures

Outcome measures
Measure	EAPVPDE n=92 Participants A daily disposable contact lens.	EADE n=92 Participants A marketed daily disposable contact lens
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire	53.61 units on a scale Standard Error 2.201 • Interval 49.27 to 57.95	48.91 units on a scale Standard Error 2.197 • Interval 44.58 to 53.25

PRIMARY outcome

Timeframe: After 7 to 9 days of lens wear

Population: Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.

The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores 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.

Outcome measures

Outcome measures
Measure	EAPVPDE n=92 Participants A daily disposable contact lens.	EADE n=92 Participants A marketed daily disposable contact lens
Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire	61.21 units on a scale Standard Error 1.847 • Interval 57.56 to 64.86	51.77 units on a scale Standard Error 1.842 • Interval 48.12 to 55.41

Adverse Events

EAPVPDE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EADE

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

Michael Mayers, OD, FAAO

Johnson & Johnson Vision Care

Phone: 904-443-3252

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER