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Trial Outcomes & Findings for Clinical Evaluation of Lapsed Contact Lens Wearers Who Are Re-fit Into Senofilcon A Contact Lenses (NCT NCT01990664)

NCT ID: NCT01990664

Last Updated: 2018-06-19

Results Overview

Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

199 participants

Primary outcome timeframe

4 weeks

Results posted on

2018-06-19

Participant Flow

A total of 199 subjects were enrolled in the study; 7 subjects were enrolled but not randomized. 18 subjects were discontinued and 174 subjects completed the study. Of those 174 completed subjects, 5 subjects had major protocol deviations; 169 subjects were included in the analysis.

Participant milestones

Participant milestones
Measure
Control (Senfilcon A)
Subjects that were randomized to receive the Control lens for the duration of the study.
Test (Senofilcon A)
Subjects that were randomized to receive theTest lens for the duration of the study.
Overall Study
STARTED
102
90
Overall Study
COMPLETED
95
79
Overall Study
NOT COMPLETED
7
11

Reasons for withdrawal

Reasons for withdrawal
Measure
Control (Senfilcon A)
Subjects that were randomized to receive the Control lens for the duration of the study.
Test (Senofilcon A)
Subjects that were randomized to receive theTest lens for the duration of the study.
Overall Study
Lost to Follow-up
2
6
Overall Study
Withdrawal by Subject
2
3
Overall Study
Protocol Violation
1
0
Overall Study
Lens Discomfort
1
1
Overall Study
Lens Handling Difficulties
1
0
Overall Study
Unsatisfactory Visual Response
0
1

Baseline Characteristics

Clinical Evaluation of Lapsed Contact Lens Wearers Who Are Re-fit Into Senofilcon A Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control (Senfilcon A)
n=102 Participants
Consists of subjects that were dispensed at least one Control lens.
Test (Senofilcon A)
n=90 Participants
Consists of subjects that were dispensed at least one Test lens.
Total
n=192 Participants
Total of all reporting groups
Age, Continuous
29.80 years
STANDARD_DEVIATION 6.356 • n=5 Participants
29.22 years
STANDARD_DEVIATION 5.715 • n=7 Participants
29.57 years
STANDARD_DEVIATION 6.096 • n=5 Participants
Sex: Female, Male
Female
69 Participants
n=5 Participants
62 Participants
n=7 Participants
131 Participants
n=5 Participants
Sex: Female, Male
Male
33 Participants
n=5 Participants
28 Participants
n=7 Participants
61 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
Race/Ethnicity, Customized
Asian
3 participants
n=5 Participants
2 participants
n=7 Participants
5 participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
20 participants
n=5 Participants
22 participants
n=7 Participants
42 participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
1 participants
n=5 Participants
0 participants
n=7 Participants
1 participants
n=5 Participants
Race/Ethnicity, Customized
White
78 participants
n=5 Participants
65 participants
n=7 Participants
143 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
United States
102 participants
n=5 Participants
90 participants
n=7 Participants
192 participants
n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: The analysis population includes all subjects who have completed all study visits without a major protocol deviation.

Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology.

Outcome measures

Outcome measures
Measure
Control (Senofilcon A)
n=93 Participants
Subjects that were randomized to receive the Control lens for the duration of the study.
Test (Senofilcon A)
n=76 Participants
Subjects that were randomized to receive the Test lens for the duration of the study.
Proportion of Successfully Re-fitted Subjects
100 percentage of Subjects
95.52 percentage of Subjects

Adverse Events

Control (Senofilcon A)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Test (Senofilcon 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

Jurandir Araujo, Clinical Compliance Manager

Johnson & Johnson Vision Care, Inc.

Phone: 9044431379

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60