Trial Outcomes & Findings for Investigation of Ocular Signs & Symptoms in Wearers Fitted With Contact Lenses Following Digital Device Use (NCT NCT02394756)
NCT ID: NCT02394756
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. Scores range 0-120.
COMPLETED
NA
52 participants
1-Day Follow-up
2018-06-19
Participant Flow
A total of 52 subjects were enrolled in this study. Of the enrolled subjects 10 subjects did not meet the eligibility criteria and 42 subjects were dispensed study lenses. Of the dispensed subjects 37 completed the study while 5 subjects were discontinued.
Participant milestones
| Measure |
Senofilcon A/Lotrafilcon B/Comfilcon A
Subjects randomized to this sequence wore the senofilcon A lens in the first period, the lotrafilcon B lens in the second period and the comfilcon A lens in the third period.
|
Senfilcon A/Comfilcon A/Lotrafilcon B
Subjects randomized to this sequence wore the senofilcon A lens in the first period, the comfilcon A lens in the second period and the lotrafilcon B lens in the third period.
|
Lotrafilcon B/Comfilcon A/Senofilcon A
Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the comfilcon A lens in the second period and the senofilcon A lens in the third period.
|
Lotrafilcon B/Senofilcon A/Comfilcon A
Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the senofilcon A lens in the second period and the comfilcon A lens in the third period.
|
Comfilcon A/Senofilcon A/ Lotrafilcon B
Subjects randomized to this sequence wore the comfilcon A lens in the first period, the senofilcon A lens in the second period and the lotrafilcon B lens in the third period.
|
Comfilcon A/Lotrafilcon B/Senofilcon A
Subjects randomized to this sequence wore the comfilcon A lens in the first period, the lotrafilcon B lens in the second period and the senofilcon A lens in the third period.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
7
|
7
|
7
|
7
|
7
|
7
|
|
Period 1
COMPLETED
|
7
|
6
|
6
|
6
|
7
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
1
|
1
|
0
|
1
|
|
Period 2
STARTED
|
7
|
6
|
6
|
6
|
7
|
6
|
|
Period 2
COMPLETED
|
7
|
6
|
6
|
6
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 3
STARTED
|
7
|
6
|
6
|
6
|
6
|
6
|
|
Period 3
COMPLETED
|
7
|
6
|
6
|
6
|
6
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Senofilcon A/Lotrafilcon B/Comfilcon A
Subjects randomized to this sequence wore the senofilcon A lens in the first period, the lotrafilcon B lens in the second period and the comfilcon A lens in the third period.
|
Senfilcon A/Comfilcon A/Lotrafilcon B
Subjects randomized to this sequence wore the senofilcon A lens in the first period, the comfilcon A lens in the second period and the lotrafilcon B lens in the third period.
|
Lotrafilcon B/Comfilcon A/Senofilcon A
Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the comfilcon A lens in the second period and the senofilcon A lens in the third period.
|
Lotrafilcon B/Senofilcon A/Comfilcon A
Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the senofilcon A lens in the second period and the comfilcon A lens in the third period.
|
Comfilcon A/Senofilcon A/ Lotrafilcon B
Subjects randomized to this sequence wore the comfilcon A lens in the first period, the senofilcon A lens in the second period and the lotrafilcon B lens in the third period.
|
Comfilcon A/Lotrafilcon B/Senofilcon A
Subjects randomized to this sequence wore the comfilcon A lens in the first period, the lotrafilcon B lens in the second period and the senofilcon A lens in the third period.
|
|---|---|---|---|---|---|---|
|
Period 1
Lens Discomfort
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
0
|
0
|
|
Period 2
Unsatisfactory Visual Response
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Investigation of Ocular Signs & Symptoms in Wearers Fitted With Contact Lenses Following Digital Device Use
Baseline characteristics by cohort
| Measure |
Dispensed Subjects
n=42 Participants
All subjects that were dispensed at least 1 study lens.
|
|---|---|
|
Age, Continuous
|
24.0 years
STANDARD_DEVIATION 4.74 • n=99 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
21 participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
42 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1-Day Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
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. Scores range 0-120.
Outcome measures
| Measure |
Senofilcon A
n=37 Participants
Subjects wore the senofilcon A lens in any of the three periods during the study.
|
Lotrafilcon B
n=37 Participants
Subjects wore the lotrafilcon B lens in any of the three periods during the study.
|
Comfilcon A
n=37 Participants
Subjects wore the comfilcon A lens in any of the three periods during the study.
|
|---|---|---|---|
|
Subjective Overall Comfort
|
65.0 units on a scale
Standard Deviation 19.76
|
53.6 units on a scale
Standard Deviation 23.34
|
61.9 units on a scale
Standard Deviation 22.70
|
PRIMARY outcome
Timeframe: 1-Day Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Subjective Overall quality of vision 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. Scores range 0-120.
Outcome measures
| Measure |
Senofilcon A
n=37 Participants
Subjects wore the senofilcon A lens in any of the three periods during the study.
|
Lotrafilcon B
n=37 Participants
Subjects wore the lotrafilcon B lens in any of the three periods during the study.
|
Comfilcon A
n=37 Participants
Subjects wore the comfilcon A lens in any of the three periods during the study.
|
|---|---|---|---|
|
Subjective Overall Quality of Vision
|
63.6 units on a scale
Standard Deviation 17.76
|
63.8 units on a scale
Standard Deviation 18.24
|
65.8 units on a scale
Standard Deviation 18.39
|
Adverse Events
Senofilcon A
Lotrafilcon B
Comfilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Senofilcon A
n=42 participants at risk
Subjects wore the senofilcon A lens in any of the three periods during the study.
|
Lotrafilcon B
n=42 participants at risk
Subjects wore the lotrafilcon B lens in any of the three periods during the study.
|
Comfilcon A
n=42 participants at risk
Subjects wore the comfilcon A lens in any of the three periods during the study.
|
|---|---|---|---|
|
Eye disorders
Non-Significant Infiltrate Event
|
7.1%
3/42 • Number of events 5 • Throughout the duration of the study. Approximately 4-weeks per subject.
|
0.00%
0/42 • Throughout the duration of the study. Approximately 4-weeks per subject.
|
4.8%
2/42 • Number of events 2 • Throughout the duration of the study. Approximately 4-weeks per subject.
|
|
Immune system disorders
Common Cold
|
0.00%
0/42 • Throughout the duration of the study. Approximately 4-weeks per subject.
|
0.00%
0/42 • Throughout the duration of the study. Approximately 4-weeks per subject.
|
4.8%
2/42 • Number of events 2 • Throughout the duration of the study. Approximately 4-weeks per subject.
|
Additional Information
Chantal Coles-Brennan- PRINCIPAL RESEARCH OPTOMETRIST
Johnson & Johnson Vision Care Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60