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Trial Outcomes & Findings for A Comparison of Two Daily Disposable Soft Contact Lenses (NCT NCT02427477)

NCT ID: NCT02427477

Last Updated: 2018-06-19

Results Overview

Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

1-week Follow-up

Results posted on

2018-06-19

Participant Flow

A total of 120 subjects were enrolled into this study. All enrolled subjects were dispensed a study lens. Of the dispensed subjects 1 was discontinued from the study and 119 subjects completed the study.

Participant milestones

Participant milestones
Measure
Senofilcon A / Delefilcon A/ Senofilcon A
Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.
Delefilcon A / Senofilcon A / Delefilcon A
Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore delefilcon A contact lens, then wore the senofilcon A second and then wore the delefilcon A contact lens third.
Period 1
STARTED
60
60
Period 1
COMPLETED
59
60
Period 1
NOT COMPLETED
1
0
Period 2
STARTED
59
60
Period 2
COMPLETED
59
60
Period 2
NOT COMPLETED
0
0
Period 3
STARTED
59
60
Period 3
COMPLETED
59
60
Period 3
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Senofilcon A / Delefilcon A/ Senofilcon A
Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.
Delefilcon A / Senofilcon A / Delefilcon A
Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore delefilcon A contact lens, then wore the senofilcon A second and then wore the delefilcon A contact lens third.
Period 1
Adverse Event
1
0

Baseline Characteristics

A Comparison of Two Daily Disposable Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Senofilcon A / Delefilcon A / Senofilcon A
n=60 Participants
All subjects that randomized to receive this sequence and were dispensed a study lens.
Delefilcon A / Senofilcon A / Delefilcon A
n=60 Participants
All subjects that randomized to receive this sequence and were dispensed a study lens.
Total
n=120 Participants
Total of all reporting groups
Age, Continuous
28.6 years
STANDARD_DEVIATION 6.14 • n=5 Participants
27.6 years
STANDARD_DEVIATION 4.97 • n=7 Participants
28.0 years
STANDARD_DEVIATION 5.60 • n=5 Participants
Sex: Female, Male
Female
42 Participants
n=5 Participants
38 Participants
n=7 Participants
80 Participants
n=5 Participants
Sex: Female, Male
Male
18 Participants
n=5 Participants
22 Participants
n=7 Participants
40 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
11 Participants
n=5 Participants
3 Participants
n=7 Participants
14 Participants
n=5 Participants
Race (NIH/OMB)
White
47 Participants
n=5 Participants
52 Participants
n=7 Participants
99 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
60 participants
n=5 Participants
60 participants
n=7 Participants
120 participants
n=5 Participants

PRIMARY outcome

Timeframe: 1-week Follow-up

Population: The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).

Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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.

Outcome measures

Outcome measures
Measure
Senofilcon A
n=178 Observations
Subjects that received the senofilcon A contact lens in at least one of the three study periods.
Delefilcon A
n=179 Observations
Subjects that received the delefilcon A contact lens in at least one of the three study periods.
Subjective Overall Comfort
75.5 units on a scale
Standard Deviation 28.12
70.8 units on a scale
Standard Deviation 28.60

PRIMARY outcome

Timeframe: 1-week Follow-up

Population: The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).

Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison scores (CLUE). 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.

Outcome measures

Outcome measures
Measure
Senofilcon A
n=178 Observations
Subjects that received the senofilcon A contact lens in at least one of the three study periods.
Delefilcon A
n=179 Observations
Subjects that received the delefilcon A contact lens in at least one of the three study periods.
Subjective Overall Vision
75.3 units on a scale
Standard Deviation 22.04
72.1 units on a scale
Standard Deviation 24.05

Adverse Events

Senofilcon A

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

Delefilcon 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

John R. Buch, O.D., M.S., F.A.A.O.

Johnson & Johnson Vision Care Inc.

Phone: 904-443-3500

Results disclosure agreements

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

Restriction type: LTE60