Trial Outcomes & Findings for Clinical Characterization of Symptomatic Populations (NCT NCT03319212)
NCT ID: NCT03319212
Last Updated: 2019-10-15
Results Overview
Meibomian gland imaging was assessed in each each subject eye, at baseline, 4-Week Follow-up (during lens wear) and the the 5-Week Follow-up on subjects' bare eyes. Meibomian gland imaging is expressed interms of area of loss using the following grading scale: Degree 0 ≈ 0%; Degree 1 ≤ 25%; Degree 2 26% - 50%; Degree 3 51% - 75%; Degree 4 ≥ 75%.
COMPLETED
NA
105 participants
4-Week Follow-up
2019-10-15
Participant Flow
A total of 105 subjects were enrolled into this study. Of those enrolled 81, were dispensed a study lens while 24 subjects failed to meet all eligibility criteria. Of those dispensed a study lens, 73 completed the study while 8 subjects were discontinued. All subjects were disepsned the same study lens senofilcon A.
Subjects were stratified into two subject groups: symptomatic (baseline CLDEQ-8 score of 15 or greater) and asymptomatic (baseline CLDEQ-8 score of 7 or lower).
Participant milestones
| Measure |
Asymptomatic
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study. All subjects wore the senofilcon A lens in both eyes throughout the entire duration.
|
Symptomatic
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study. All subjects wore the senofilcon A lens in both eyes throughout the entire duration.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
52
|
|
Overall Study
COMPLETED
|
26
|
47
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Asymptomatic
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study. All subjects wore the senofilcon A lens in both eyes throughout the entire duration.
|
Symptomatic
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study. All subjects wore the senofilcon A lens in both eyes throughout the entire duration.
|
|---|---|---|
|
Overall Study
Discontinued as moving out of local area
|
0
|
1
|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Clinical Characterization of Symptomatic Populations
Baseline characteristics by cohort
| Measure |
Asymptomatic
n=29 Participants
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
|
Symptomatic
n=52 Participants
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.76 Years
STANDARD_DEVIATION 7.229 • n=5 Participants
|
28.17 Years
STANDARD_DEVIATION 9.096 • n=7 Participants
|
28.38 Years
STANDARD_DEVIATION 8.4333 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
18 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-Week Follow-upPopulation: All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.
Meibomian gland imaging was assessed in each each subject eye, at baseline, 4-Week Follow-up (during lens wear) and the the 5-Week Follow-up on subjects' bare eyes. Meibomian gland imaging is expressed interms of area of loss using the following grading scale: Degree 0 ≈ 0%; Degree 1 ≤ 25%; Degree 2 26% - 50%; Degree 3 51% - 75%; Degree 4 ≥ 75%.
Outcome measures
| Measure |
Asymptomatic
n=52 Eyes
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
|
Symptomatic
n=94 Eyes
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
|
|---|---|---|
|
Meibomian Gland Imaging
Degree 0
|
10 eyes
|
4 eyes
|
|
Meibomian Gland Imaging
Degree 1
|
23 eyes
|
66 eyes
|
|
Meibomian Gland Imaging
Degree 2
|
18 eyes
|
16 eyes
|
|
Meibomian Gland Imaging
Degree 3
|
1 eyes
|
8 eyes
|
PRIMARY outcome
Timeframe: 4-Week Follow-upPopulation: All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.
Meibomian glands were assessed in the three regions of each lower eyelid: temporal, central, and nasal. Approximately five glands are expressed per region with each use of the Meibomian Gland Evaluator. Secretions for each of the 5 glands selected within the three regions were graded using the following secretion grading scale: Grade 0 = No Secretion (Includes capped orifices), Grade 1 = Inspissated (semi-solid, toothpaste-like consistency), Grade 2 = Colored/Cloudy Liquid, Grade 3 = Clear Liquid Oil. The total grades for 5 glands per region was calculated for each subject. The total Meibomian Gland Secretion Score was calculated by adding the grades for the 15 glands assessed. Mean and standard deviation for total grade per region and total Meibomian Gland Secretion Score were reported for each stratum. Total scores range from 0 to 15 were lower score indicate worsening meibomian gland expressability.
Outcome measures
| Measure |
Asymptomatic
n=52 Eyes
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
|
Symptomatic
n=94 Eyes
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
|
|---|---|---|
|
Meibomian Gland Expressibility
Central Lower Lid
|
9.04 Score on a Scale
Standard Deviation 5.068
|
8.07 Score on a Scale
Standard Deviation 5.055
|
|
Meibomian Gland Expressibility
Temporal Lower Lid
|
8.71 Score on a Scale
Standard Deviation 4.795
|
7.94 Score on a Scale
Standard Deviation 4.803
|
|
Meibomian Gland Expressibility
Nasal Lower Lid
|
7.94 Score on a Scale
Standard Deviation 4.976
|
6.54 Score on a Scale
Standard Deviation 4.571
|
|
Meibomian Gland Expressibility
Total Score
|
25.69 Score on a Scale
Standard Deviation 13.964
|
22.55 Score on a Scale
Standard Deviation 12.649
|
PRIMARY outcome
Timeframe: 4-Week Follow-upPopulation: All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.
Lid margin evaluation was conducted for upper and lower lids for both left and right eyes. The presence of the following biomicroscopy findings were recorded as No/normal or Yes/abnormal: * Irregularity: Notching of Margin * Vascularity of Lid Margin: Telangiectasia * Meibomian Gland Pouting, Plugging, or Capping * Lid/Lash Margin Debris Findings. The number of positive findings (yes) was reported for each group.
Outcome measures
| Measure |
Asymptomatic
n=52 Eyes
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
|
Symptomatic
n=94 Eyes
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
|
|---|---|---|
|
Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings
Lid/Lash Margin Debris Findings
|
0 Number of eyes
|
10 Number of eyes
|
|
Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings
Irregularity: Notching of Margin
|
1 Number of eyes
|
5 Number of eyes
|
|
Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings
Vascularity of Lid Margin: Telangiectasia
|
12 Number of eyes
|
21 Number of eyes
|
|
Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings
Meibomian Gland Pouting, Plugging, or Capping
|
12 Number of eyes
|
33 Number of eyes
|
PRIMARY outcome
Timeframe: 4-Week Follow-upPopulation: All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.
Horizontal length of staining and sagittal width of staining were graded for both upper and lower lids for each eye. Average grade was calculated separately for upper and lower lids, and the final grade was calculated as the average grade across upper and lower lids. Mean and standard deviation were reported for the final grade by stratum. Subjects were classified according to their final lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Final Grades range from 0 to 3, where higher final grades indicate worsening lid wiper epitheliopathy.
Outcome measures
| Measure |
Asymptomatic
n=52 Eyes
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
|
Symptomatic
n=94 Eyes
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
|
|---|---|---|
|
Lid Wiper Epitheliopathy
|
0.50 Units on a scale
Standard Deviation 0.718
|
0.28 Units on a scale
Standard Deviation 0.489
|
PRIMARY outcome
Timeframe: 4-Week Follow-upPopulation: All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.
Lid-parallel conjunctival folds (LIPCOF) will be evaluated in the area perpendicular to the temporal and nasal limbus on the bulbar conjunctiva above the lower lid (temporal and nasal LIPCOF, respectively), and classified using the LIPCOF grading scale: 0 = No conjunctival folds, 1 = One permanent and clear parallel fold, 2 = Two permanent and clear parallel folds (normally lower than 0.2mm), and 3 = More than two permanent and clear parallel folds (normally higher than 0.2mm).
Outcome measures
| Measure |
Asymptomatic
n=52 Eyes
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
|
Symptomatic
n=94 Eyes
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
|
|---|---|---|
|
Conjunctival Folds
Temporal- Grade 0
|
27 eyes
|
45 eyes
|
|
Conjunctival Folds
Temporal- Grade 1
|
22 eyes
|
41 eyes
|
|
Conjunctival Folds
Temporal- Grade 2
|
3 eyes
|
8 eyes
|
|
Conjunctival Folds
Temporal- Grade 3
|
0 eyes
|
0 eyes
|
|
Conjunctival Folds
Nasal- Grade 0
|
43 eyes
|
55 eyes
|
|
Conjunctival Folds
Nasal- Grade 1
|
9 eyes
|
30 eyes
|
|
Conjunctival Folds
Nasal- Grade 2
|
0 eyes
|
9 eyes
|
|
Conjunctival Folds
Nasal- Grade 3
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: 4-Week Follow-upPopulation: All subjects dispensed a study lens.
Limbal and bulbar conjunctival redness were assessed or each quadrant (nasal, temporal, inferior, superior) using the following scale: 0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe.
Outcome measures
| Measure |
Asymptomatic
n=54 Eyes
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
|
Symptomatic
n=96 Eyes
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
|
|---|---|---|
|
Conjunctival Redness
Limbal-Superior- Grade 3
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Bulbar-Nasal- Grade 0
|
12 eyes
|
11 eyes
|
|
Conjunctival Redness
Bulbar-Nasal- Grade 1
|
36 eyes
|
72 eyes
|
|
Conjunctival Redness
Bulbar-Nasal- Grade 2
|
6 eyes
|
13 eyes
|
|
Conjunctival Redness
Bulbar-Nasal- Grade 3
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Bulbar-Nasal- Grade 4
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Bulbar-Temporal- Grade 0
|
13 eyes
|
12 eyes
|
|
Conjunctival Redness
Bulbar-Temporal- Grade 1
|
37 eyes
|
73 eyes
|
|
Conjunctival Redness
Bulbar-Temporal- Grade 2
|
4 eyes
|
11 eyes
|
|
Conjunctival Redness
Bulbar-Temporal- Grade 3
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Bulbar-Temporal- Grade 4
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Bulbar-Inferior-Grade 0
|
23 eyes
|
27 eyes
|
|
Conjunctival Redness
Bulbar-Inferior-Grade 1
|
31 eyes
|
66 eyes
|
|
Conjunctival Redness
Bulbar-Inferior-Grade 2
|
0 eyes
|
3 eyes
|
|
Conjunctival Redness
Bulbar-Inferior-Grade 3
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Bulbar-Inferior-Grade 4
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Bulbar-Superior- Grade 0
|
23 eyes
|
31 eyes
|
|
Conjunctival Redness
Bulbar-Superior- Grade 1
|
30 eyes
|
57 eyes
|
|
Conjunctival Redness
Bulbar-Superior- Grade 2
|
1 eyes
|
8 eyes
|
|
Conjunctival Redness
Bulbar-Superior- Grade 3
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Bulbar-Superior- Grade 4
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Limbal-Nasal- Grade 0
|
26 eyes
|
28 eyes
|
|
Conjunctival Redness
Limbal-Nasal- Grade 1
|
25 eyes
|
66 eyes
|
|
Conjunctival Redness
Limbal-Nasal- Grade 2
|
3 eyes
|
2 eyes
|
|
Conjunctival Redness
Limbal-Nasal- Grade 3
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Limbal-Nasal- Grade 4
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Limbal-Temporal- Grade 0
|
24 eyes
|
33 eyes
|
|
Conjunctival Redness
Limbal-Temporal- Grade 1
|
28 eyes
|
58 eyes
|
|
Conjunctival Redness
Limbal-Temporal- Grade 2
|
2 eyes
|
5 eyes
|
|
Conjunctival Redness
Limbal-Temporal- Grade 3
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Limbal-Temporal- Grade 4
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Limbal-Inferior- Grade 0
|
27 eyes
|
40 eyes
|
|
Conjunctival Redness
Limbal-Inferior- Grade 1
|
27 eyes
|
55 eyes
|
|
Conjunctival Redness
Limbal-Inferior- Grade 2
|
0 eyes
|
1 eyes
|
|
Conjunctival Redness
Limbal-Inferior- Grade 3
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Limbal-Inferior- Grade 4
|
0 eyes
|
0 eyes
|
|
Conjunctival Redness
Limbal-Superior- Grade 0
|
25 eyes
|
46 eyes
|
|
Conjunctival Redness
Limbal-Superior- Grade 1
|
29 eyes
|
45 eyes
|
|
Conjunctival Redness
Limbal-Superior- Grade 2
|
0 eyes
|
5 eyes
|
|
Conjunctival Redness
Limbal-Superior- Grade 4
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: 4-Week Follow-upPopulation: All subjects dispensed a study lens.
Conjunctival staining was assessed for each eye by quadrant (Superior, Inferior, Nasal, Temporal) utilizing the following scale: Grade 0 = None (No conjunctival staining), Grade 1 = Trace (Scattered superficial punctate staining), Grade 2 = Mild (Regional or generalized punctate staining), Grade 3 = Moderate (Significant coalesced punctate staining), Grade 4 = Severe (Patch staining).
Outcome measures
| Measure |
Asymptomatic
n=54 Eyes
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
|
Symptomatic
n=96 Eyes
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
|
|---|---|---|
|
Conjunctival Staining
Superior- Grade 0
|
28 eyes
|
50 eyes
|
|
Conjunctival Staining
Nasal- Grade 0
|
17 eyes
|
17 eyes
|
|
Conjunctival Staining
Nasal- Grade 1
|
18 eyes
|
51 eyes
|
|
Conjunctival Staining
Nasal- Grade 2
|
19 eyes
|
28 eyes
|
|
Conjunctival Staining
Nasal- Grade 3
|
0 eyes
|
0 eyes
|
|
Conjunctival Staining
Temporal- Grade 0
|
20 eyes
|
29 eyes
|
|
Conjunctival Staining
Temporal- Grade 1
|
19 eyes
|
51 eyes
|
|
Conjunctival Staining
Temporal- Grade 2
|
15 eyes
|
16 eyes
|
|
Conjunctival Staining
Temporal- Grade 3
|
0 eyes
|
0 eyes
|
|
Conjunctival Staining
Inferior-Grade 0
|
26 eyes
|
30 eyes
|
|
Conjunctival Staining
Inferior-Grade 1
|
9 eyes
|
51 eyes
|
|
Conjunctival Staining
Inferior-Grade 2
|
19 eyes
|
13 eyes
|
|
Conjunctival Staining
Inferior-Grade 3
|
0 eyes
|
2 eyes
|
|
Conjunctival Staining
Superior- Grade 1
|
18 eyes
|
44 eyes
|
|
Conjunctival Staining
Superior- Grade 2
|
8 eyes
|
2 eyes
|
|
Conjunctival Staining
Superior- Grade 3
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: 4-Week Follow-upPopulation: All subjects dispensed a study lens.
Corneal staining was assessed for each eye by region (Central, Superior, Inferior, Nasal, Temporal). Corneal staining type was evaluated using the following the scale: Grade 0 = None, Grade 1 = Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate, and Grade 4 = Patch (\>1mm). Corneal staining area was evaluated using the following the scale: 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. The following scale was used in the grading of corneal staining depth: Grade 0 = None, Grade 0 = Superficial epithelial, Grade 2 = Full epithelial, and Grade 3 = Stromal glow.
Outcome measures
| Measure |
Asymptomatic
n=54 Eyes
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
|
Symptomatic
n=96 Eyes
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
|
|---|---|---|
|
Corneal Staining
Staining- Area- Central- Grade 0
|
51 eyes
|
89 eyes
|
|
Corneal Staining
Staining- Area- Inferior- Grade 3
|
3 eyes
|
2 eyes
|
|
Corneal Staining
Staining- Area-Nasal-Grade 6
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Area-Temporal-Grade 4
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Area-Temporal-Grade 5
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Depth-Nasal-Grade 1
|
5 eyes
|
3 eyes
|
|
Corneal Staining
Staining-Depth-Nasal-Grade 2
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining Type- Central- Grade 0
|
51 eyes
|
88 eyes
|
|
Corneal Staining
Staining Type- Central- Grade 1
|
1 eyes
|
5 eyes
|
|
Corneal Staining
Staining Type- Central- Grade 2
|
2 eyes
|
3 eyes
|
|
Corneal Staining
Staining Type- Central- Grade 3
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining Type-Inferior - Grade 0
|
48 eyes
|
75 eyes
|
|
Corneal Staining
Staining Type-Inferior - Grade 1
|
5 eyes
|
17 eyes
|
|
Corneal Staining
Staining Type-Inferior - Grade 2
|
1 eyes
|
4 eyes
|
|
Corneal Staining
Staining Type-Inferior - Grade 3
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining Type-Nasal - Grade 0
|
49 eyes
|
92 eyes
|
|
Corneal Staining
Staining Type-Nasal - Grade 1
|
4 eyes
|
2 eyes
|
|
Corneal Staining
Staining Type-Nasal - Grade 2
|
1 eyes
|
2 eyes
|
|
Corneal Staining
Staining Type-Nasal - Grade 3
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining Type-Temporal-Grade 0
|
51 eyes
|
92 eyes
|
|
Corneal Staining
Staining Type-Temporal-Grade 1
|
2 eyes
|
2 eyes
|
|
Corneal Staining
Staining Type-Temporal-Grade 2
|
1 eyes
|
2 eyes
|
|
Corneal Staining
Staining Type-Temporal-Grade 3
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining Type- Superior- Grade 0
|
50 eyes
|
88 eyes
|
|
Corneal Staining
Staining Type- Superior- Grade 1
|
4 eyes
|
6 eyes
|
|
Corneal Staining
Staining Type- Superior- Grade 2
|
0 eyes
|
2 eyes
|
|
Corneal Staining
Staining Type- Superior- Grade 3
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining- Area- Central- Grade 1
|
1 eyes
|
4 eyes
|
|
Corneal Staining
Staining- Area- Central- Grade 2
|
1 eyes
|
2 eyes
|
|
Corneal Staining
Staining- Area- Central- Grade 3
|
1 eyes
|
1 eyes
|
|
Corneal Staining
Staining- Area- Central- Grade 4
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining- Area- Central- Grade 5
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining- Area- Central- Grade 6
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining- Area- Inferior- Grade 0
|
48 eyes
|
76 eyes
|
|
Corneal Staining
Staining- Area- Inferior- Grade 1
|
3 eyes
|
10 eyes
|
|
Corneal Staining
Staining- Area- Inferior- Grade 2
|
0 eyes
|
8 eyes
|
|
Corneal Staining
Staining- Area- Inferior- Grade 4
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining- Area- Inferior- Grade 5
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining- Area- Inferior- Grade 6
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining- Area-Nasal-Grade 0
|
49 eyes
|
93 eyes
|
|
Corneal Staining
Staining- Area-Nasal-Grade 1
|
4 eyes
|
2 eyes
|
|
Corneal Staining
Staining- Area-Nasal-Grade 2
|
1 eyes
|
1 eyes
|
|
Corneal Staining
Staining- Area-Nasal-Grade 3
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining- Area-Nasal-Grade 4
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining- Area-Nasal-Grade 5
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Area-Temporal-Grade 0
|
51 eyes
|
92 eyes
|
|
Corneal Staining
Staining-Area-Temporal-Grade 1
|
1 eyes
|
2 eyes
|
|
Corneal Staining
Staining-Area-Temporal-Grade 2
|
2 eyes
|
2 eyes
|
|
Corneal Staining
Staining-Area-Temporal-Grade 3
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Area-Temporal-Grade 6
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Area-Superior-Grade 0
|
50 eyes
|
89 eyes
|
|
Corneal Staining
Staining-Area-Superior-Grade 1
|
3 eyes
|
4 eyes
|
|
Corneal Staining
Staining-Area-Superior-Grade 2
|
0 eyes
|
3 eyes
|
|
Corneal Staining
Staining-Area-Superior-Grade 3
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Area-Superior-Grade 4
|
1 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Area-Superior-Grade 5
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Area-Superior-Grade 6
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Depth-Central-Grade 0
|
51 eyes
|
89 eyes
|
|
Corneal Staining
Staining-Depth-Central-Grade 1
|
3 eyes
|
7 eyes
|
|
Corneal Staining
Staining-Depth-Central-Grade 2
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Depth-Inferior-Grade 0
|
48 eyes
|
77 eyes
|
|
Corneal Staining
Staining-Depth-Inferior-Grade 1
|
6 eyes
|
19 eyes
|
|
Corneal Staining
Staining-Depth-Inferior-Grade 2
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Depth-Nasal-Grade 0
|
49 eyes
|
93 eyes
|
|
Corneal Staining
Staining-Depth-Temporal-Grade 0
|
51 eyes
|
93 eyes
|
|
Corneal Staining
Staining-Depth-Temporal-Grade 1
|
3 eyes
|
3 eyes
|
|
Corneal Staining
Staining-Depth-Temporal-Grade 2
|
0 eyes
|
0 eyes
|
|
Corneal Staining
Staining-Depth-Superior-Grade 0
|
50 eyes
|
89 eyes
|
|
Corneal Staining
Staining-Depth-Superior-Grade 1
|
4 eyes
|
7 eyes
|
|
Corneal Staining
Staining-Depth-Superior-Grade 2
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: 4-Week Follow-upPopulation: All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.
Tear film lipid layer thickness was measured for each eye using LipiView II. The Review Lipid Images screen provided numerical analysis of the measured lipid layer thickness in nanometers (nm) from 10 (thinnest) to 240 (thickest), with a precision of 1 nm and an accuracy of 10 nm.
Outcome measures
| Measure |
Asymptomatic
n=52 Eyes
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
|
Symptomatic
n=94 Eyes
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
|
|---|---|---|
|
Tear Film Lipid Layer Thickness
|
66.81 nm
Standard Deviation 19.336
|
63.00 nm
Standard Deviation 16.208
|
SECONDARY outcome
Timeframe: 4-Week Follow-upPopulation: All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.
Non-invasive tear break-up time (NIBUT) was measured for each eye to indicate the stability of the tear film. NIBUT is measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort. Three measurements were taken on each eye. The average NIBUT was reported for each group.
Outcome measures
| Measure |
Asymptomatic
n=52 Eyes
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
|
Symptomatic
n=94 Eyes
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
|
|---|---|---|
|
Tear Film Stability
|
8.03 seconds
Standard Deviation 3.846
|
6.78 seconds
Standard Deviation 4.327
|
SECONDARY outcome
Timeframe: 4-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Tear film lipid pattern was recorded for each eye using the following categories: None, Open Meshwork, Closed (Tight Meshwork), Flow (Wave), Amorphous, Colors, and Other.
Outcome measures
| Measure |
Asymptomatic
n=52 Eyes
Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study
|
Symptomatic
n=94 Eyes
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
|
|---|---|---|
|
Tear Film Lipid Pattern
None
|
0 eyes
|
0 eyes
|
|
Tear Film Lipid Pattern
Open Meshwork
|
6 eyes
|
24 eyes
|
|
Tear Film Lipid Pattern
Closed (Tight)
|
18 eyes
|
22 eyes
|
|
Tear Film Lipid Pattern
Flow (Wave)
|
14 eyes
|
28 eyes
|
|
Tear Film Lipid Pattern
Amorphous
|
11 eyes
|
15 eyes
|
|
Tear Film Lipid Pattern
Colors
|
3 eyes
|
5 eyes
|
|
Tear Film Lipid Pattern
Others
|
0 eyes
|
0 eyes
|
Adverse Events
Senofilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elizabeth Dow, OD, FAAO - 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