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Trial Outcomes & Findings for Clinical Evaluation of Two Daily Disposable Contact Lenses (NCT NCT01875471)

NCT ID: NCT01875471

Last Updated: 2018-06-19

Results Overview

After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

279 participants

Primary outcome timeframe

Day 7

Results posted on

2018-06-19

Participant Flow

A total of 279 subjects were enrolled in the study; 4 did not meet the eligibility criteria, 2 prematurely discontinued and 273 completed the study. Of those 273 completers, 23 were excluded from the primary analysis due to major protocol deviations; hence, 250 completed the study per protocol and were included in the analysis.

Participant milestones

Participant milestones
Measure
Delefilcon A
Spherical daily disposable soft contact lens
Narafilcon A
Spherical daily disposable soft contact lens with UV blocking
Overall Study
STARTED
137
138
Overall Study
Completed Per Protocol
127
123
Overall Study
COMPLETED
136
137
Overall Study
NOT COMPLETED
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Delefilcon A
Spherical daily disposable soft contact lens
Narafilcon A
Spherical daily disposable soft contact lens with UV blocking
Overall Study
Adverse Event
0
1
Overall Study
Unsatisfactory Lens Fitting
1
0

Baseline Characteristics

Clinical Evaluation of Two Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Delefilcon A
n=137 Participants
Spherical daily disposable soft contact lens delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily
Narafilcon A
n=138 Participants
Spherical daily disposable soft contact lens Class 1 UV blocking narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily
Total
n=275 Participants
Total of all reporting groups
Age, Categorical
<=18 years
11 Participants
n=5 Participants
9 Participants
n=7 Participants
20 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
126 Participants
n=5 Participants
129 Participants
n=7 Participants
255 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
30.0 years
STANDARD_DEVIATION 8.17 • n=5 Participants
29.0 years
STANDARD_DEVIATION 7.69 • n=7 Participants
29.5 years
STANDARD_DEVIATION 7.93 • n=5 Participants
Sex: Female, Male
Female
99 Participants
n=5 Participants
76 Participants
n=7 Participants
175 Participants
n=5 Participants
Sex: Female, Male
Male
38 Participants
n=5 Participants
62 Participants
n=7 Participants
100 Participants
n=5 Participants
Region of Enrollment
United Kingdom
88 participants
n=5 Participants
87 participants
n=7 Participants
175 participants
n=5 Participants
Region of Enrollment
United States
49 participants
n=5 Participants
51 participants
n=7 Participants
100 participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 7

After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).

Outcome measures

Outcome measures
Measure
Delefilcon A
n=127 Participants
Spherical daily disposable soft contact lens
Narafilcon A
n=123 Participants
Spherical daily disposable soft contact lens with UV blocking
Subjective Ease of Lens Removal
Good
24 participants
10 participants
Subjective Ease of Lens Removal
Excellent
45 participants
76 participants
Subjective Ease of Lens Removal
Very Good
23 participants
34 participants
Subjective Ease of Lens Removal
Fair
23 participants
3 participants
Subjective Ease of Lens Removal
Poor
12 participants
0 participants

Adverse Events

Delefilcon A

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

Narafilcon 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

Daria Wicks

Johnson & Johnson Vision Care

Phone: 1 904 443-1391

Results disclosure agreements

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

Restriction type: GT60