Trial Outcomes & Findings for Clinical Long-Term Evaluation of Approved and Investigational Contact Lenses (NCT NCT02625233)

Results Overview

Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The proportion of subject eyes with SLF grade 3 or higher was reported for each lens.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

105 participants

Primary outcome timeframe

Up to 6 Month Follow-up

Results posted on

2017-06-19

Participant Flow

A total of 105 subjects were enrolled into this study. Of the enrolled subjects all were dispensed a study lens. Out of all the dispensed subjects 103 completed the study while 2 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Senofilcon C Subjects that wore the senofilcon C lens throughout the entire duration of the study.	Comfilcon A Subjects that wore the comfilcon A lens throughout the entire duration of the study.
Overall Study STARTED	49	56
Overall Study COMPLETED	47	56
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon C Subjects that wore the senofilcon C lens throughout the entire duration of the study.	Comfilcon A Subjects that wore the comfilcon A lens throughout the entire duration of the study.
Overall Study Adverse Event	2	0

Baseline Characteristics

Clinical Long-Term Evaluation of Approved and Investigational Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Senofilcon C n=49 Participants Subjects that wore the senofilcon C lens throughout the entire duration of the study.	Comfilcon A n=56 Participants Subjects that wore the comfilcon A lens throughout the entire duration of the study.	Total n=105 Participants Total of all reporting groups
Age, Continuous	31.2 Years STANDARD_DEVIATION 7.03 • n=93 Participants	31.5 Years STANDARD_DEVIATION 7.31 • n=4 Participants	31.4 Years STANDARD_DEVIATION 7.15 • n=27 Participants
Sex: Female, Male Female	36 Participants n=93 Participants	35 Participants n=4 Participants	71 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	21 Participants n=4 Participants	34 Participants n=27 Participants
Race/Ethnicity, Customized Asian	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized White	43 Participants n=93 Participants	52 Participants n=4 Participants	95 Participants n=27 Participants
Region of Enrollment United States	49 Participants n=93 Participants	56 Participants n=4 Participants	105 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 6 Month Follow-up

Population: Subjects that were dispensed a study lens.

Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The proportion of subject eyes with SLF grade 3 or higher was reported for each lens.

Outcome measures

Outcome measures
Measure	Senofilcon C n=376 Subject Eyes Subjects that wore the senofilcon C lens througout the entire duration of the study.	Comfilcon A n=448 Subject Eyes Subjects that wore the comfilcon A lens throughout the entire duration of the study.
Proportion of Eyes Grade 3 or Higher SLF	0 Proporiton of Subject Eyes	0 Proporiton of Subject Eyes

PRIMARY outcome

Timeframe: Up to 6 Month Follow-up

Population: Subjects that completed all study visits.

The visual acuity (LogMAR) was collected at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The average Visual Acuity (logMAR) across the 4 study visits and at each individual visit was reported for each lens.

Outcome measures

Outcome measures
Measure	Senofilcon C n=376 Subject Eyes Subjects that wore the senofilcon C lens througout the entire duration of the study.	Comfilcon A n=448 Subject Eyes Subjects that wore the comfilcon A lens throughout the entire duration of the study.
Visual Acuity (logMAR) Overall N=376, N=448	-0.12 LogMAR Standard Deviation 0.066	-0.12 LogMAR Standard Deviation 0.074
Visual Acuity (logMAR) Initial Visit N=94, N=112	-0.14 LogMAR Standard Deviation 0.069	-0.13 LogMAR Standard Deviation 0.064
Visual Acuity (logMAR) 4 Month Follow-up N=94, N=112	-0.12 LogMAR Standard Deviation 0.069	-0.13 LogMAR Standard Deviation 0.075
Visual Acuity (logMAR) 5 Month Follow-up N=94, N=112	-0.13 LogMAR Standard Deviation 0.068	-0.12 LogMAR Standard Deviation 0.078
Visual Acuity (logMAR) 6 Month Follow-up N=94, N=112	-0.12 LogMAR Standard Deviation 0.063	-0.13 LogMAR Standard Deviation 0.072

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

Johson & 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