Trial Outcomes & Findings for Evaluation of a Johnson & Johnson Vision Care Investigational Contact Lens Compared to a Marketed Monthly Replacement Contact Lens (NCT NCT02515994)

Results Overview

Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

224 participants

Primary outcome timeframe

Up to 3 Month Follow-up

Results posted on

2016-07-15

Participant Flow

A total of 224 subjects were enrolled in this study. Of the enrolled subjects 3 did not meet the eligibility criteria and 221 were dispensed a study lens. Of the dispensed subjects 204 completed the study while 17 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Senofilcon C Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.	Comfilcon A Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
Overall Study STARTED	109	112
Overall Study COMPLETED	99	105
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon C Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.	Comfilcon A Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
Overall Study Protocol Violation	3	5
Overall Study No Longer Meets Eligibility Criteria	2	1
Overall Study Adverse Event	3	1
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Evaluation of a Johnson & Johnson Vision Care Investigational Contact Lens Compared to a Marketed Monthly Replacement Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Senofilcon C n=109 Participants Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.	Comfilcon A n=112 Participants Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.	Total n=221 Participants Total of all reporting groups
Age, Continuous	30.4 years STANDARD_DEVIATION 7.26 • n=5 Participants	30.9 years STANDARD_DEVIATION 7.33 • n=7 Participants	30.7 years STANDARD_DEVIATION 7.24 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	71 Participants n=7 Participants	150 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	41 Participants n=7 Participants	71 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants	112 participants n=7 Participants	221 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 Month Follow-up

Population: All subjects that were dispensed a study lens.

Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported.

Outcome measures

Outcome measures
Measure	Senofilcon C n=218 Subject Eyes Subjects that wore the senofilcon C lens throughout the entire study.	Comfilcon A n=224 Subject Eyes Subjects that wore the comfilcon A lens throughout the entire study.
Slit Lamp Findings	3 Eyes	2 Eyes

PRIMARY outcome

Timeframe: Up to 3 month Follow-up

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

Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported.

Outcome measures

Outcome measures
Measure	Senofilcon C n=198 Number of Observations Subjects that wore the senofilcon C lens throughout the entire study.	Comfilcon A n=210 Number of Observations Subjects that wore the comfilcon A lens throughout the entire study.
Visual Acuity	-0.11 LogMAR Standard Deviation 0.073	-0.12 LogMAR Standard Deviation 0.073

SECONDARY outcome

Timeframe: Up to 3 month Follow-up

Population: All subjects that were dispensed a study lens.

Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item "Experienced Eye Symptoms or Problems?" were reported.

Outcome measures

Outcome measures
Measure	Senofilcon C n=218 Subject Eyes Subjects that wore the senofilcon C lens throughout the entire study.	Comfilcon A n=224 Subject Eyes Subjects that wore the comfilcon A lens throughout the entire study.
Symptoms	153 Eyes	225 Eyes

SECONDARY outcome

Timeframe: 3 month Follow-up

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

Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported.

Outcome measures

Outcome measures
Measure	Senofilcon C n=99 Participants Subjects that wore the senofilcon C lens throughout the entire study.	Comfilcon A n=105 Participants Subjects that wore the comfilcon A lens throughout the entire study.
Average Wear Time	14.88 Hours per day Standard Deviation 1.713	14.90 Hours per day Standard Deviation 1.576

Adverse Events

Senofilcon C

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Comfilcon A

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Senofilcon C n=109 participants at risk Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.	Comfilcon A n=112 participants at risk Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
Eye disorders Non-Significant Ocular Event	4.6% 5/109 • Number of events 5 • Throughout the entire duration of the study. Approximately 5 months.	4.5% 5/112 • Number of events 5 • Throughout the entire duration of the study. Approximately 5 months.

Additional Information

Kristy Canavan, O.D., F.A.A.O. Principle 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