Trial Outcomes & Findings for One Month Daily Wear Clinical Evaluation of New Prototype Contact Lenses in Habitual and Neophyte Contact Lens Wearers (NCT NCT02081677)
NCT ID: NCT02081677
Last Updated: 2018-06-19
Results Overview
Corneal Staining Area was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 11-point scale (i.e. Grade 0= 0% of region covered, Grade 1 =10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4= 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered,Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered and Grade 10 = 100% of region covered). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.
COMPLETED
NA
80 participants
Baseline and 4-Week Follow-up
2018-06-19
Participant Flow
A total of 80 subjects were enrolled in this study. Of the enrolled subjects 4 did not meet the eligibility criteria and 76 were randomized to receive a study lens. Of the randomized subjects 72 completed the study.
Participant milestones
| Measure |
Etafilcon A
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
19
|
19
|
|
Overall Study
COMPLETED
|
18
|
18
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Etafilcon A
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
No Longer Meets Eligibility Criteria
|
0
|
0
|
1
|
0
|
|
Overall Study
Not comfortable with lens care system
|
1
|
0
|
0
|
0
|
|
Overall Study
Unsatisfactory Lens Fitting
|
0
|
1
|
0
|
0
|
Baseline Characteristics
One Month Daily Wear Clinical Evaluation of New Prototype Contact Lenses in Habitual and Neophyte Contact Lens Wearers
Baseline characteristics by cohort
| Measure |
Etafilcon A
n=19 Participants
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=19 Participants
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=19 Participants
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=19 Participants
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
23.42 years
STANDARD_DEVIATION 4.611 • n=5 Participants
|
24.58 years
STANDARD_DEVIATION 4.706 • n=7 Participants
|
23.16 years
STANDARD_DEVIATION 5.336 • n=5 Participants
|
20.84 years
STANDARD_DEVIATION 2.192 • n=4 Participants
|
23.0 years
STANDARD_DEVIATION 4.211 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian Indian
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
19 participants
n=4 Participants
|
76 participants
n=21 Participants
|
|
Region of Enrollment
India
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
19 participants
n=4 Participants
|
76 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: The analysis population consist of all subjects that completed all study visits without a major protocol.
Corneal Staining Area was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 11-point scale (i.e. Grade 0= 0% of region covered, Grade 1 =10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4= 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered,Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered and Grade 10 = 100% of region covered). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.
Outcome measures
| Measure |
Etafilcon A
n=34 Subject Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Subject Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Subject Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Subject Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Corneal Staining (Area)
Baseline
|
11.76 Units on a scale
Standard Deviation 24.676
|
5.79 Units on a scale
Standard Deviation 18.4
|
4.17 Units on a scale
Standard Deviation 6.918
|
6.18 Units on a scale
Standard Deviation 17.925
|
|
Corneal Staining (Area)
4-week Follow-up
|
5.29 Units on a scale
Standard Deviation 12.367
|
4.21 Units on a scale
Standard Deviation 9.482
|
8.06 Units on a scale
Standard Deviation 7.491
|
9.69 Units on a scale
Standard Deviation 8.224
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: The analysis population consist of all subjects that completed all study visits without a major protocol.
Corneal Staining Depth was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 4-point scale (i.e. Grade 0= None, Grade 1 =Superficial epithelial, Grade 2 = Full epithelial, Grade 3 =stromal glow). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.
Outcome measures
| Measure |
Etafilcon A
n=34 Subject Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Subject Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Subject Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Subject Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Corneal Staining (Depth)
Baseline
|
1.03 Units on a scale
Standard Deviation 2.037
|
0.45 Units on a scale
Standard Deviation 1.224
|
0.36 Units on a scale
Standard Deviation 0.593
|
0.44 Units on a scale
Standard Deviation 1.045
|
|
Corneal Staining (Depth)
4-week Follow-up
|
0.53 Units on a scale
Standard Deviation 1.237
|
0.42 Units on a scale
Standard Deviation 0.948
|
0.81 Units on a scale
Standard Deviation 0.749
|
0.97 Units on a scale
Standard Deviation 0.822
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: The analysis population consist of all subjects that completed all study visits without a major protocol.
Corneal Staining was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 =Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate and Grade 4 = Patch (greater or equal to 1mm). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.
Outcome measures
| Measure |
Etafilcon A
n=34 Subject Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Subject Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Subject Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Subject Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Corneal Staining (Type)
4-week Follow-up
|
0.53 Units on a scale
Standard Deviation 1.237
|
0.42 Units on a scale
Standard Deviation 0.948
|
0.81 Units on a scale
Standard Deviation 0.749
|
0.94 Units on a scale
Standard Deviation 0.801
|
|
Corneal Staining (Type)
Baseline
|
1.03 Units on a scale
Standard Deviation 2.037
|
0.58 Units on a scale
Standard Deviation 1.840
|
0.42 Units on a scale
Standard Deviation 0.692
|
0.59 Units on a scale
Standard Deviation 1.829
|
PRIMARY outcome
Timeframe: Baseline and 2-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Limbal Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Limbal Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for limbal redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.
Outcome measures
| Measure |
Etafilcon A
n=17 Participants
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Subject Eye
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Subject Eye
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Subject Eye
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Limbal Conjunctival Redness
Baseline
|
4.0 units on a scale
Standard Deviation 1.822
|
3.50 units on a scale
Standard Deviation 1.564
|
3.72 units on a scale
Standard Deviation 1.485
|
4.06 units on a scale
Standard Deviation 1.294
|
|
Limbal Conjunctival Redness
2-week Follow-up
|
3.93 units on a scale
Standard Deviation 1.441
|
3.54 units on a scale
Standard Deviation 1.472
|
3.72 units on a scale
Standard Deviation 1.446
|
3.53 units on a scale
Standard Deviation 1.646
|
PRIMARY outcome
Timeframe: Baseline and 2-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Bulbar Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Bulbar Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for bulbar redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.
Outcome measures
| Measure |
Etafilcon A
n=34 Subject Eye
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Subject Eye
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Subject Eye
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Subject Eye
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Bulbar Conjunctival Redness
Baseline
|
4.04 units on a scale
Standard Deviation 1.378
|
4.12 units on a scale
Standard Deviation 1.416
|
4.08 units on a scale
Standard Deviation 1.099
|
4.24 units on a scale
Standard Deviation 1.136
|
|
Bulbar Conjunctival Redness
2-week Follow-up
|
4.13 units on a scale
Standard Deviation 1.170
|
4.47 units on a scale
Standard Deviation 0.870
|
4.18 units on a scale
Standard Deviation 1.166
|
4.28 units on a scale
Standard Deviation 1.431
|
PRIMARY outcome
Timeframe: 4-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations. The average visual acuity (LogMAR) for each lens was reported.
Outcome measures
| Measure |
Etafilcon A
n=34 Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Visual Acuity (LogMAR)
|
-0.15 LogMAR
Standard Deviation 0.078
|
-0.12 LogMAR
Standard Deviation 0.067
|
-0.13 LogMAR
Standard Deviation 0.076
|
-0.13 LogMAR
Standard Deviation 0.086
|
PRIMARY outcome
Timeframe: Post Lens Fitting and 4-Week Follow-upPopulation: The analysis population consists of all subjects that completed all study visits without a major protocol deviation.
Lens fit was assessed for each subject eye at post lens fitting and 4- week follow-up evaluations. Lens fit is a binary response as acceptable or unacceptable lens fit. The percentage of eyes with acceptable lens fit was reported.
Outcome measures
| Measure |
Etafilcon A
n=34 Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Lens Fitting Characteristics
Post Lens Fitting
|
100 Percentage of Eyes
|
100 Percentage of Eyes
|
100 Percentage of Eyes
|
100 Percentage of Eyes
|
|
Lens Fitting Characteristics
4-week Follow-up
|
100 Percentage of Eyes
|
100 Percentage of Eyes
|
100 Percentage of Eyes
|
100 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
The Ocular symptom Burning/Stinging was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Outcome measures
| Measure |
Etafilcon A
n=34 Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Percentage of Reported Ocular Symptoms (Burning/Stinging)
Baseline
|
5.9 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
|
Percentage of Reported Ocular Symptoms (Burning/Stinging)
4- Week Follow-up
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
6.3 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Corneal Edema was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.
Outcome measures
| Measure |
Etafilcon A
n=34 Subject Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Subject Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Subject Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Subject Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Corneal Edema
Baseline
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
|
Corneal Edema
4-week Follow-up
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Conjunctival Injection was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.
Outcome measures
| Measure |
Etafilcon A
n=34 Subject Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Subject Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Subject Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Subject Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Conjunctival Injection
Baseline
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
|
Conjunctival Injection
4-week Follow-up
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Corneal Neovascularization was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.
Outcome measures
| Measure |
Etafilcon A
n=34 Subject Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Subject Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Subject Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Subject Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Corneal Neovascularization
4-week Follow-up
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
|
Corneal Neovascularization
Baseline
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Corneal Staining was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.
Outcome measures
| Measure |
Etafilcon A
n=34 Subject Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Subject Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Subject Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Subject Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Corneal Staining
Baseline
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
|
Corneal Staining
4-week Follow-up
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
PRIMARY outcome
Timeframe: 1-, 2- and 4-Week Follow-upPopulation: The analysis population consists of all subjects that completed all study visits without a major protocol deviation.
Tarsal abnormalities were assessed using a biomicroscope at baseline, post lens fitting, 1-, 2- and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0, 1, 2, 3 and 4) with grade 0 represents the absence of abnormalities and 1 to 4 representing successively worse abnormalities (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The percentage of eyes with Grade 3 or higher was reported.
Outcome measures
| Measure |
Etafilcon A
n=17 Participants
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=19 Participants
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=18 Participants
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Subject Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Tarsal Abnormalities
1-week Follow-up
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
|
Tarsal Abnormalities
2-week Follow-up
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
|
Tarsal Abnormalities
4-week Follow-up
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
0 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
The Ocular symptom Cloudy/Blurry/Hazy was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Outcome measures
| Measure |
Etafilcon A
n=34 Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy)
Baseline
|
0.0 Percentage of Eyes
|
5.3 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
|
Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy)
4- Week Follow-up
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
The Ocular symptom Dryness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Outcome measures
| Measure |
Etafilcon A
n=34 Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Percentage of Reported Ocular Symptoms (Dryness)
Baseline
|
5.9 Percentage of Eyes
|
15.8 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
|
Percentage of Reported Ocular Symptoms (Dryness)
4- Week Follow-up
|
5.9 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
The Ocular symptom Grittiness/Foreign Body Sensation was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Outcome measures
| Measure |
Etafilcon A
n=34 Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation)
Baseline
|
0.0 Percentage of Eyes
|
5.3 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
|
Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation)
4- Week Follow-up
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
The Ocular symptom Irritation/Discomfort was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Outcome measures
| Measure |
Etafilcon A
n=34 Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Percentage of Reported Ocular Symptoms (Irritation/Discomfort)
Baseline
|
0.0 Percentage of Eyes
|
5.3 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
|
Percentage of Reported Ocular Symptoms (Irritation/Discomfort)
4- Week Follow-up
|
5.9 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
The Ocular symptom Itchiness/Scratchiness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Outcome measures
| Measure |
Etafilcon A
n=34 Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness)
Baseline
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
|
Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness)
4- Week Follow-up
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
The Ocular symptom Lens awareness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Outcome measures
| Measure |
Etafilcon A
n=34 Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Percentage of Reported Ocular Symptoms (Lens Awareness)
Baseline
|
0.0 Percentage of Eyes
|
10.5 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
|
Percentage of Reported Ocular Symptoms (Lens Awareness)
4- Week Follow-up
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
The Ocular symptom Redness wasassessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Outcome measures
| Measure |
Etafilcon A
n=34 Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Percentage of Reported Ocular Symptoms (Redness)
Baseline
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
|
Percentage of Reported Ocular Symptoms (Redness)
4- Week Follow-up
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
PRIMARY outcome
Timeframe: Baseline and 4-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
The Ocular symptom Variable Vision was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Outcome measures
| Measure |
Etafilcon A
n=34 Eyes
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=38 Eyes
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=36 Eyes
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=32 Eyes
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Percentage of Reported Ocular Symptoms (Variable Vision)
Baseline
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
|
Percentage of Reported Ocular Symptoms (Variable Vision)
4- Week Follow-up
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
0.0 Percentage of Eyes
|
Adverse Events
Etafilcon A
Prototype E1
Prototype E2
Prototype E3
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Etafilcon A
n=19 participants at risk
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
|
Prototype E1
n=19 participants at risk
Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study.
|
Prototype E2
n=19 participants at risk
Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study.
|
Prototype E3
n=19 participants at risk
Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study.
|
|---|---|---|---|---|
|
Eye disorders
Non-significant Ocular Event
|
5.3%
1/19 • Number of events 1 • Throughout the duration of the study. Approximately 5 months.
|
5.3%
1/19 • Number of events 1 • Throughout the duration of the study. Approximately 5 months.
|
21.1%
4/19 • Number of events 6 • Throughout the duration of the study. Approximately 5 months.
|
5.3%
1/19 • Number of events 1 • Throughout the duration of the study. Approximately 5 months.
|
|
Blood and lymphatic system disorders
Low Blood Pressure
|
0.00%
0/19 • Throughout the duration of the study. Approximately 5 months.
|
0.00%
0/19 • Throughout the duration of the study. Approximately 5 months.
|
0.00%
0/19 • Throughout the duration of the study. Approximately 5 months.
|
5.3%
1/19 • Number of events 1 • Throughout the duration of the study. Approximately 5 months.
|
|
Gastrointestinal disorders
Upset Stomach
|
0.00%
0/19 • Throughout the duration of the study. Approximately 5 months.
|
0.00%
0/19 • Throughout the duration of the study. Approximately 5 months.
|
0.00%
0/19 • Throughout the duration of the study. Approximately 5 months.
|
5.3%
1/19 • Number of events 1 • Throughout the duration of the study. Approximately 5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Sprain
|
0.00%
0/19 • Throughout the duration of the study. Approximately 5 months.
|
0.00%
0/19 • Throughout the duration of the study. Approximately 5 months.
|
0.00%
0/19 • Throughout the duration of the study. Approximately 5 months.
|
5.3%
1/19 • Number of events 1 • Throughout the duration of the study. Approximately 5 months.
|
|
Blood and lymphatic system disorders
Minimal Skin Bruises
|
0.00%
0/19 • Throughout the duration of the study. Approximately 5 months.
|
0.00%
0/19 • Throughout the duration of the study. Approximately 5 months.
|
0.00%
0/19 • Throughout the duration of the study. Approximately 5 months.
|
5.3%
1/19 • Number of events 1 • Throughout the duration of the study. Approximately 5 months.
|
Additional Information
Tawnya Wilson, 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