Trial Outcomes & Findings for Evaluation of an Investigational Multifocal Lens (NCT NCT02223754)
NCT ID: NCT02223754
Last Updated: 2018-06-19
Results Overview
CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
COMPLETED
NA
371 participants
8 -12 days post wear
2018-06-19
Participant Flow
This study enrolled a total of 371 subjects. Of those enrolled subjects 49 did not meet the eligibility criteria and 322 subjects were dispensed a study lens. Of the dispensed subjects 297 completed the study and 25 were discontinued from the study.
Participant milestones
| Measure |
Etafilcon A / Lotrafilcon B
Subjects were randomized to one of two lens sequences. Subjects first received the etafilcon A contact lens and then received the Control lens (lotrafilcon B contact lens.
|
Lotrafilcon B/ Etafilcon A
Subjects were randomized to one of two lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
|
|---|---|---|
|
Period 1
STARTED
|
163
|
159
|
|
Period 1
COMPLETED
|
159
|
144
|
|
Period 1
NOT COMPLETED
|
4
|
15
|
|
Period 2
STARTED
|
159
|
144
|
|
Period 2
COMPLETED
|
156
|
141
|
|
Period 2
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Etafilcon A / Lotrafilcon B
Subjects were randomized to one of two lens sequences. Subjects first received the etafilcon A contact lens and then received the Control lens (lotrafilcon B contact lens.
|
Lotrafilcon B/ Etafilcon A
Subjects were randomized to one of two lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
0
|
|
Period 1
Lost to Follow-up
|
0
|
1
|
|
Period 1
Protocol Violation
|
2
|
4
|
|
Period 1
Withdrawal by Subject
|
0
|
4
|
|
Period 1
Test Article No Longer Available
|
1
|
5
|
|
Period 1
Unsatisfactory Visual Response
|
0
|
1
|
|
Period 2
Adverse Event
|
0
|
1
|
|
Period 2
Protocol Violation
|
1
|
0
|
|
Period 2
Lens Discomfort
|
1
|
1
|
|
Period 2
Lost to Follow-up
|
1
|
0
|
|
Period 2
Test Article No Longer Available
|
0
|
1
|
Baseline Characteristics
Evaluation of an Investigational Multifocal Lens
Baseline characteristics by cohort
| Measure |
Etafilcon A / Lotrafilcon B
n=163 Participants
Subjects that were randomized to this sequence and were dispensed a study lens.
|
Lotrafilcon B / Etafilcon A
n=159 Participants
Subjects that were randomized to this sequence and were dispensed a study lens.
|
Total
n=322 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Hyperopes, N=59, N=53, N=112
|
52.3 years
STANDARD_DEVIATION 6.59 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 7.04 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 6.78 • n=5 Participants
|
|
Age, Continuous
Myopes, N=104, N=106, N=210
|
49.3 years
STANDARD_DEVIATION 6.10 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 5.77 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 5.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
147 participants
n=5 Participants
|
144 participants
n=7 Participants
|
291 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
|
163 participants
n=5 Participants
|
159 participants
n=7 Participants
|
322 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 -12 days post wearPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Outcome measures
| Measure |
Etafilcon A
n=275 Participants
Subjects that received the etafilcon A contact lens during either the first or second period of the study.
|
Lotrafilcon B
n=275 Participants
Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
|
|---|---|---|
|
Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
Hyperopes, N=94, N=94
|
51.15 units on a scale
Standard Deviation 21.647
|
54.28 units on a scale
Standard Deviation 20.749
|
|
Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
Myopes, N=181, N=181
|
53.55 units on a scale
Standard Deviation 18.644
|
51.84 units on a scale
Standard Deviation 19.319
|
PRIMARY outcome
Timeframe: 8- 12 Days post wearPopulation: The analysis population consists of subjects that have completed all study visits without a major protocol deviation.
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
Outcome measures
| Measure |
Etafilcon A
n=275 Participants
Subjects that received the etafilcon A contact lens during either the first or second period of the study.
|
Lotrafilcon B
n=275 Participants
Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
|
|---|---|---|
|
Distance Binocular Visual Acuity (LogMAR)
Hyperopes, N=94, N=94
|
-0.069 LogMAR
Standard Deviation 0.0908
|
-0.066 LogMAR
Standard Deviation 0.0982
|
|
Distance Binocular Visual Acuity (LogMAR)
Myopes, N=180, N=181
|
-0.100 LogMAR
Standard Deviation 0.0991
|
-0.093 LogMAR
Standard Deviation 0.0981
|
PRIMARY outcome
Timeframe: 8-12 days post wearPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Outcome measures
| Measure |
Etafilcon A
n=275 Participants
Subjects that received the etafilcon A contact lens during either the first or second period of the study.
|
Lotrafilcon B
n=275 Participants
Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
|
|---|---|---|
|
Intermediate Binocular Visual Acuity (LogMAR)
Hyperopes, N=94, N=94
|
-0.061 LogMAR
Standard Deviation 0.0829
|
-0.050 LogMAR
Standard Deviation 0.0897
|
|
Intermediate Binocular Visual Acuity (LogMAR)
Myopes, N=180, N=181
|
-0.081 LogMAR
Standard Deviation 0.0803
|
-0.063 LogMAR
Standard Deviation 0.0894
|
PRIMARY outcome
Timeframe: 8-12 days post wearPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Outcome measures
| Measure |
Etafilcon A
n=275 Participants
Subjects that received the etafilcon A contact lens during either the first or second period of the study.
|
Lotrafilcon B
n=275 Participants
Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
|
|---|---|---|
|
Near Binocular Visual Acuity (LogMAR)
Hyperopes, N=94, N=94
|
0.050 LogMAR
Standard Deviation 0.0970
|
0.074 LogMAR
Standard Deviation 0.1035
|
|
Near Binocular Visual Acuity (LogMAR)
Myopes, N=180, N=181
|
0.034 LogMAR
Standard Deviation 0.1039
|
0.049 LogMAR
Standard Deviation 0.1176
|
PRIMARY outcome
Timeframe: 8 - 12 Days post wearPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Outcome measures
| Measure |
Etafilcon A
n=550 Subject Eyes
Subjects that received the etafilcon A contact lens during either the first or second period of the study.
|
Lotrafilcon B
n=550 Subject Eyes
Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
|
|---|---|---|
|
Corneal Staining
Hyperopes, N=188, N=188
|
0.0 percentage of Subject Eyes
|
0.0 percentage of Subject Eyes
|
|
Corneal Staining
Myopes, N=362, N=362
|
0.0 percentage of Subject Eyes
|
0.0 percentage of Subject Eyes
|
PRIMARY outcome
Timeframe: 8- 12 Days post wearPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Outcome measures
| Measure |
Etafilcon A
n=550 Subject Eyes
Subjects that received the etafilcon A contact lens during either the first or second period of the study.
|
Lotrafilcon B
n=550 Subject Eyes
Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
|
|---|---|---|
|
Bulbar Conjunctival Injection
Hyperopes, N=188, N=188
|
0.0 Percentage of Subject Eyes
|
0.0 Percentage of Subject Eyes
|
|
Bulbar Conjunctival Injection
Myopes, N=362 , N=362
|
0.0 Percentage of Subject Eyes
|
0.0 Percentage of Subject Eyes
|
PRIMARY outcome
Timeframe: 8- 12 Days post wearPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Outcome measures
| Measure |
Etafilcon A
n=550 Subject Eyes
Subjects that received the etafilcon A contact lens during either the first or second period of the study.
|
Lotrafilcon B
n=550 Subject Eyes
Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
|
|---|---|---|
|
Limbal Conjunctival Injection
Hyperopes, N=188, N=188
|
0.0 Percentage of Subject Eyes
|
0.0 Percentage of Subject Eyes
|
|
Limbal Conjunctival Injection
Myopes, N=362, N=362
|
0.0 Percentage of Subject Eyes
|
0.0 Percentage of Subject Eyes
|
PRIMARY outcome
Timeframe: 8- 12 Days post wearPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.
Outcome measures
| Measure |
Etafilcon A
n=550 Subject Eyes
Subjects that received the etafilcon A contact lens during either the first or second period of the study.
|
Lotrafilcon B
n=550 Subject Eyes
Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
|
|---|---|---|
|
Contact Lens Fitting
Hyperopes, N=188, N=188
|
100 Percentage of Subject Eyes
|
100 Percentage of Subject Eyes
|
|
Contact Lens Fitting
Myopes, N=362, N=362
|
99.5 Percentage of Subject Eyes
|
100 Percentage of Subject Eyes
|
Adverse Events
Etafilcon A
Lotrafilcon B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas R. Karkkainen, O.D., M.S., F.A.A.O., Sr. Principal Research Optemtrist
Johnson & Johnson Vision Care Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60