Trial Outcomes & Findings for Clinical Evaluation of Approved and Investigational Contact Lenses (NCT NCT02669095)

Last Updated: 2017-06-09

Results Overview

Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported.

Recruitment status

COMPLETED

Study phase

Target enrollment

150 participants

Primary outcome timeframe

Up to 4 Week Follow-up

Results posted on

2017-06-09

Participant Flow

A total of 150 subjects were enrolled in this study. All subjects enrolled into the study were dispensed a study lens. Of the dispensed subjects 146 completed the study and 4 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Senofilcon C Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.	Comfilcon A Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
Overall Study STARTED	75	75
Overall Study COMPLETED	74	72
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon C Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.	Comfilcon A Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
Overall Study Adverse Event	1	0
Overall Study Unsatisfactory Lens Fitting	0	1
Overall Study Torn Lens	0	1
Overall Study Visit 5 assessments not completed	0	1

Baseline Characteristics

Clinical Evaluation of Approved and Investigational Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Senofilcon C n=75 Participants Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.	Comfilcon A n=75 Participants Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.	Total n=150 Participants Total of all reporting groups
Age, Continuous	28.2 Years STANDARD_DEVIATION 6.05 • n=5 Participants	30.2 Years STANDARD_DEVIATION 5.62 • n=7 Participants	29.2 Years STANDARD_DEVIATION 5.91 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	61 Participants n=7 Participants	116 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized White	61 Participants n=5 Participants	65 Participants n=7 Participants	126 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment North America	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 Week Follow-up

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

Outcome measures

Outcome measures
Measure	Senofilcon C n=740 Subject Eyes Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.	Comfilcon A n=720 Subject Eyes Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
Acceptable Lens Fitting	1 Proportion of eyes	0.99 Proportion of eyes

PRIMARY outcome

Timeframe: Up to 4 Week Follow-up

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

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. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit.

Outcome measures

Outcome measures
Measure	Senofilcon C n=74 Participants Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.	Comfilcon A n=72 Participants Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
Overall Comfort 1-Week Follow-up	71.75 Units on a scale Standard Deviation 22.193	56.68 Units on a scale Standard Deviation 27.747
Overall Comfort 2-Week Follow-up	70.58 Units on a scale Standard Deviation 22.500	54.69 Units on a scale Standard Deviation 30.268
Overall Comfort 3-Week Follow-up	68.75 Units on a scale Standard Deviation 26.108	53.43 Units on a scale Standard Deviation 29.912
Overall Comfort 4-Week Follow-up	68.25 Units on a scale Standard Deviation 27.137	54.57 Units on a scale Standard Deviation 30.522

Adverse Events

Senofilcon C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfilcon 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

Kristy Canavan, O.D., FAAO Principal Research Optometrist

Johnson & Johnson Vision Care Inc.

Phone: 904 443-1474

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60