Trial Outcomes & Findings for Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population (NCT NCT01763047)
NCT ID: NCT01763047
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
298 participants
8-12 days post wear
2018-06-19
Participant Flow
This study enrolled a total of 298 subjects. Subjects were stratified as either Hyperopes or Myopes, which was determined by their sphere power. Of the enrolled subjects 22 did not meet the eligibility criteria and 276 subjects were randomized a study lens. Of the randomized subjects 29 were discontinued and 247 subjects completed the study.
Participant milestones
| Measure |
Etafilcon A/ Lotrafilcon B
Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A lens and then received the lotrafilcon B lens.
|
Lotrafilcon B/ Etafilcon A
Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
|
|---|---|---|
|
Period 1
STARTED
|
139
|
137
|
|
Period 1
Myopes
|
77
|
76
|
|
Period 1
Hyperopes
|
62
|
61
|
|
Period 1
COMPLETED
|
130
|
126
|
|
Period 1
NOT COMPLETED
|
9
|
11
|
|
Period 2
STARTED
|
130
|
126
|
|
Period 2
Myopes
|
74
|
72
|
|
Period 2
Hyperopes
|
56
|
54
|
|
Period 2
COMPLETED
|
126
|
121
|
|
Period 2
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Etafilcon A/ Lotrafilcon B
Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A lens and then received the lotrafilcon B lens.
|
Lotrafilcon B/ Etafilcon A
Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
|
|---|---|---|
|
Period 1
Test Article Not Available
|
4
|
1
|
|
Period 1
Protocol Violation
|
4
|
4
|
|
Period 1
No Longer Meets Eligibility criteria
|
1
|
0
|
|
Period 1
Adverse Event
|
0
|
1
|
|
Period 1
Unsatisfactory Visual Response
|
0
|
3
|
|
Period 1
Lens Power Not Available
|
0
|
1
|
|
Period 1
Study Site office Closed
|
0
|
1
|
|
Period 2
Lens Discomfort
|
1
|
0
|
|
Period 2
No longer meets Eligibility Criteria
|
1
|
0
|
|
Period 2
Study Site office Closed
|
1
|
1
|
|
Period 2
Unsatisfactory Visual Response
|
1
|
1
|
|
Period 2
Protocol Violation
|
0
|
2
|
|
Period 2
Unsatisfactory lens Fitting
|
0
|
1
|
Baseline Characteristics
Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population
Baseline characteristics by cohort
| Measure |
Etafilcon A/ Lotrafilcon B
n=139 Participants
Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A and then received the lotrafilcon B.
|
Lotrafilcon B/ Etafilcon A
n=137 Participants
Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B and then received the etafilcon A.
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.49 years
STANDARD_DEVIATION 6.626 • n=5 Participants
|
50.90 years
STANDARD_DEVIATION 6.775 • n=7 Participants
|
50.69 years
STANDARD_DEVIATION 6.691 • n=5 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
121 participants
n=5 Participants
|
123 participants
n=7 Participants
|
244 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
139 participants
n=5 Participants
|
137 participants
n=7 Participants
|
276 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. The analysis was conducted on each lens and strata.
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m\^2. The test was presented under the condition High luminance (250 cd/m\^2) High Contrast (90%)
Outcome measures
| Measure |
Etafilcon A
n=207 Participants
Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
|
Lotrafilcon B
n=207 Participants
Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
|
|---|---|---|
|
Binocular Distance Visual Acuity (LogMAR)
Hyperopes, N=91, 91
|
-0.068 LogMAR
Standard Deviation 0.0885
|
-0.058 LogMAR
Standard Deviation 0.0867
|
|
Binocular Distance Visual Acuity (LogMAR)
Myopes, N=116, N=116
|
-0.109 LogMAR
Standard Deviation 0.0826
|
-0.107 LogMAR
Standard Deviation 0.0835
|
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 each lens and strata.
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m\^2. The test was presented under the condition High Luminance (250cd/m\^2) High Contrast (90%).
Outcome measures
| Measure |
Etafilcon A
n=207 Participants
Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
|
Lotrafilcon B
n=207 Participants
Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
|
|---|---|---|
|
Binocular Near Visual Acuity (logMAR)
Hyperopes, N=91, N=91
|
0.063 LogMAR
Standard Deviation 0.1070
|
0.082 LogMAR
Standard Deviation 0.1316
|
|
Binocular Near Visual Acuity (logMAR)
Myopes, N=116, N=116
|
0.048 LogMAR
Standard Deviation 0.1106
|
0.043 LogMAR
Standard Deviation 0.0975
|
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 for each lens and strata.
Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) 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 and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions.
Outcome measures
| Measure |
Etafilcon A
n=414 Subject Eyes
Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
|
Lotrafilcon B
n=414 Subject Eyes
Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
|
|---|---|---|
|
Percentage of Eyes With Corneal Staining Grade 3 or Higher
Hyperopes, N=182, N=182
|
0.0 Percentage of Subject Eyes
|
0.0 Percentage of Subject Eyes
|
|
Percentage of Eyes With Corneal Staining Grade 3 or Higher
Myopes, N=232, N=232
|
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 for each lens and strata.
The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) 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 Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.
Outcome measures
| Measure |
Etafilcon A
n=414 Subject Eyes
Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
|
Lotrafilcon B
n=414 Subject Eyes
Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
|
|---|---|---|
|
Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher
Hyperopes, N=182, N=182
|
0.0 Percentage of Subject Eyes
|
0.0 Percentage of Subject Eyes
|
|
Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher
Myopes, N=232, N=232
|
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 for each lens and strata.
Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) 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 for the maximum grade of all 4 regions.
Outcome measures
| Measure |
Etafilcon A
n=414 Subject Eyes
Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
|
Lotrafilcon B
n=414 Subject Eyes
Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
|
|---|---|---|
|
Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher
Hyperopes, N=182, N=182
|
0.0 Percentage of Subject Eyes
|
0.0 Percentage of Subject Eyes
|
|
Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher
Myopes, N=232, N=232
|
0.0 Percentage of Subject Eyes
|
0.0 Percentage of Subject Eyes
|
PRIMARY outcome
Timeframe: 8-12 days post wearPopulation: The analysis consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.
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=207 Participants
Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
|
Lotrafilcon B
n=207 Participants
Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
|
|---|---|---|
|
CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire
Hyperopes, N=91, N=91
|
46.48 units on a scale
Standard Deviation 18.834
|
44.79 units on a scale
Standard Deviation 18.439
|
|
CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire
Myopes, N=116, N=116
|
47.74 units on a scale
Standard Deviation 19.279
|
50.17 units on a scale
Standard Deviation 20.433
|
Adverse Events
Test (Etafilcon A)
Control (Lotrafilcon B)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas R. Karkkainen, OD., M.S., F.A.A.O- Senior 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