Trial Outcomes & Findings for Clinical Performance Evaluation of Two Silicone Hydrogel Lenses (NCT NCT02756078)
NCT ID: NCT02756078
Last Updated: 2018-11-14
Results Overview
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. 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 with a range of 0-120.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Up to 4-Week Follow-up
Results posted on
2018-11-14
Participant Flow
A total of 200 subjects were enrolled into this study. Of the enrolled, 171 subjects were randomized and dispensed at least one study lens. Of the dispensed subjects, 127 completed the study while 44 subjects were discontinued.
Participant milestones
| Measure |
Senofilcon A/Samfilcon A
All subjects that received the senofilcon A lens during the first period and the samfilcon A lens during the second period.
|
Samfilcon A/Senofilcon A
All subjects that received the samfilcon A lens during the first period and the senofilcon A lens during the second period.
|
|---|---|---|
|
Period 1
STARTED
|
85
|
86
|
|
Period 1
COMPLETED
|
76
|
64
|
|
Period 1
NOT COMPLETED
|
9
|
22
|
|
Period 2
STARTED
|
76
|
64
|
|
Period 2
COMPLETED
|
70
|
57
|
|
Period 2
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Senofilcon A/Samfilcon A
All subjects that received the senofilcon A lens during the first period and the samfilcon A lens during the second period.
|
Samfilcon A/Senofilcon A
All subjects that received the samfilcon A lens during the first period and the senofilcon A lens during the second period.
|
|---|---|---|
|
Period 1
Unsatisfactory Lens Fitting
|
0
|
1
|
|
Period 1
Lost to Follow-up
|
0
|
2
|
|
Period 1
Protocol Violation
|
0
|
1
|
|
Period 1
Adverse Event
|
1
|
10
|
|
Period 1
Withdrawal by Subject
|
6
|
6
|
|
Period 1
Lens Discomfort
|
2
|
2
|
|
Period 2
Adverse Event
|
3
|
5
|
|
Period 2
Unsatisfactory Lens Fitting
|
0
|
1
|
|
Period 2
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Clinical Performance Evaluation of Two Silicone Hydrogel Lenses
Baseline characteristics by cohort
| Measure |
All Enrolled Subjects
n=200 Participants
All subjects enrolled in the study, i.e. signed informed consent form.
|
|---|---|
|
Age, Continuous
|
23.9 Years
STANDARD_DEVIATION 4.92 • n=39 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
78 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White
|
114 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=39 Participants
|
|
Region of Enrollment
Canada
|
200 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Up to 4-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. 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 with a range of 0-120.
Outcome measures
| Measure |
Senofilcon A
n=127 Participants
All subjects that wore the senofilcon A lens during either the first or second period of the study.
|
Samfilcon A
n=127 Participants
All subjects that wore the samfilcon A lens during either the first or second period of the study.
|
|---|---|---|
|
Overall CLUE Comfort
|
65.0 Units on a Scale
Standard Deviation 22.47
|
60.3 Units on a Scale
Standard Deviation 23.71
|
SECONDARY outcome
Timeframe: Up to 4-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Overall Handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. 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 with a range of 0-120.
Outcome measures
| Measure |
Senofilcon A
n=127 Participants
All subjects that wore the senofilcon A lens during either the first or second period of the study.
|
Samfilcon A
n=127 Participants
All subjects that wore the samfilcon A lens during either the first or second period of the study.
|
|---|---|---|
|
Overall CLUE Handling
|
66.7 Units on a Scale
Standard Deviation 18.58
|
52.9 Units on a Scale
Standard Deviation 22.99
|
SECONDARY outcome
Timeframe: Up to 4-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Time to haze measure the maximum time a contact lens wearers can keep their eye open without their vision becoming hazy. It was a measure of how the drying of the contact lens surface with open eyes affects vision.
Outcome measures
| Measure |
Senofilcon A
n=127 Participants
All subjects that wore the senofilcon A lens during either the first or second period of the study.
|
Samfilcon A
n=127 Participants
All subjects that wore the samfilcon A lens during either the first or second period of the study.
|
|---|---|---|
|
Time to Haze
|
9.4 seconds
Standard Deviation 5.01
|
9.7 seconds
Standard Deviation 5.65
|
SECONDARY outcome
Timeframe: Up to 4-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Average lens wear time with the study lenses were recorded in hour at each follow-up visit.
Outcome measures
| Measure |
Senofilcon A
n=127 Participants
All subjects that wore the senofilcon A lens during either the first or second period of the study.
|
Samfilcon A
n=127 Participants
All subjects that wore the samfilcon A lens during either the first or second period of the study.
|
|---|---|---|
|
Average Wear Time
|
11.5 Hours
Standard Deviation 3.57
|
11.55 Hours
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: Up to 4-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Average comfortable lens wear time with the study lenses were recorded in hour at each follow-up visit.
Outcome measures
| Measure |
Senofilcon A
n=127 Participants
All subjects that wore the senofilcon A lens during either the first or second period of the study.
|
Samfilcon A
n=127 Participants
All subjects that wore the samfilcon A lens during either the first or second period of the study.
|
|---|---|---|
|
Average Comfortable Wear Time
|
9.6 Hours
Standard Deviation 3.73
|
9.6 Hours
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: Up to 4-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Subjects reported the total duration of their digital device use and comfortable lens wear time during digital device use.
Outcome measures
| Measure |
Senofilcon A
n=127 Participants
All subjects that wore the senofilcon A lens during either the first or second period of the study.
|
Samfilcon A
n=127 Participants
All subjects that wore the samfilcon A lens during either the first or second period of the study.
|
|---|---|---|
|
Difference in Total Device Use Time and Comfortable Wear Time During Device Use
|
1.2 Hours
Standard Deviation 1.74
|
1.2 Hours
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Up to 4-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Subjects graded the comfort level at the end of the day using 5- point scale (1=excellence, 2=very good, 3=good, 4=fair and 5=poor). The average end of day comfort grade was reported for each lens type.
Outcome measures
| Measure |
Senofilcon A
n=127 Participants
All subjects that wore the senofilcon A lens during either the first or second period of the study.
|
Samfilcon A
n=127 Participants
All subjects that wore the samfilcon A lens during either the first or second period of the study.
|
|---|---|---|
|
Comfort at the End of the Day
|
2.6 units on a scale
Standard Deviation 1.21
|
2.7 units on a scale
Standard Deviation 1.26
|
Adverse Events
Senofilcon A
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Samfilcon A
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Senofilcon A
n=171 participants at risk
All subjects that wore the senofilcon A lens during either the first or second period of the study.
|
Samfilcon A
n=171 participants at risk
All subjects that wore the samfilcon A lens during either period of the study.
|
|---|---|---|
|
Eye disorders
Non-significant Infiltrative Event
|
3.5%
6/171 • Number of events 10 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
1.2%
2/171 • Number of events 2 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Allergic Conjunctivitis
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
1.8%
3/171 • Number of events 5 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant - Swollen Caruncle
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Conjunctival Redness and Staining
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
2.9%
5/171 • Number of events 5 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Bulbar Redness
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Grade 3-4 Conjunctival Staining
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
1.2%
2/171 • Number of events 3 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Symptoms, Problems or complaints requiring treatment
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 2 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Bacterial Conjunctivitis
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Keratoconjunctivitis
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 2 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Limbal Nodules
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 2 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Foreign Body
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Stye
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Bulbar and Limbal Redness
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
2.3%
4/171 • Number of events 5 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Localized Allergic Reaction
|
1.2%
2/171 • Number of events 5 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Corneal Tissue Overgrowth
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant slit lamp finding Grade 2 or less requiring treatment
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Conjunctival Redness Grade 3 or Higher
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 2 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Ear and labyrinth disorders
Ear Infection
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Reaction to Eye Drop
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 2 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Immune system disorders
Flu
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Phlyctenules
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Immune system disorders
Stomach Flu
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Superficial Deposits
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Blurred Central Vision
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Superior Arcuate
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Localized Corneal Staining
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Ocular Discomfort
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 2 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Redness
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Difficulty opening eye
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
|
Eye disorders
Non-significant Stye
|
0.58%
1/171 • Number of events 1 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
0.00%
0/171 • Throughout the entire duration of the study. Approximately 8 weeks per subject.
|
Additional Information
Chantal Coles-Brennan - PRINCIPAL RESEARCH OPTOMETRIST
Johnson & Johnson Vision Care, Inc.
Phone: 1-904-443-3449
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60