Trial Outcomes & Findings for Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film (NCT NCT03782571)
NCT ID: NCT03782571
Last Updated: 2020-05-12
Results Overview
The rate of microsphere clearance from the post-lens tear film was assessed by the C30 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where lens wear was assigned, the microsphere suspension was dispensed onto the posterior concave contact lens surface immediately prior to lens application. A series of digital images were taken over a 30-minute period (every minute for the first 10 minutes and then every 5 minutes for the next 20 minutes). Data transformed from the images were calculated by the C30 image analysis metric. Higher numbers represented greater clearance. The right eye was used to evaluate microsphere clearance.
COMPLETED
NA
34 participants
Post microsphere application over a 30 minute period
2020-05-12
Participant Flow
A total of 34 subjects were enrolled into the study. Of the enrolled 9 subjects did not meet the eligibility criteria. 22 subjects completed the study and 3 subjects were discontinued from the study.
Subjects were randomized to 1 of 4 unique lens sequences.
Participant milestones
| Measure |
Test 1\Control\Test 2\Test 3
Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Control in period 2, Test 2 in period 3, and Test 3 in period 4.
|
Test 2\Test 1\Test 3\Control
Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 1 in period 2, Test 3 in period 3, and Control in period 4.
|
Control\Test 3\Test 1\Test 2
Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 3 in period 2, Test 1 in period 3, and Test 2 in period 4.
|
Test 3\Test 2\Control\Test 1
Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 2 in period 2, Control in period 3, and 1 Test 1 in period 4.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
6
|
7
|
|
Period 1
COMPLETED
|
5
|
6
|
6
|
7
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Period 2
STARTED
|
5
|
6
|
6
|
7
|
|
Period 2
COMPLETED
|
5
|
6
|
6
|
7
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
5
|
6
|
6
|
7
|
|
Period 3
COMPLETED
|
3
|
6
|
6
|
7
|
|
Period 3
NOT COMPLETED
|
2
|
0
|
0
|
0
|
|
Period 4
STARTED
|
3
|
6
|
6
|
7
|
|
Period 4
COMPLETED
|
3
|
6
|
6
|
7
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test 1\Control\Test 2\Test 3
Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Control in period 2, Test 2 in period 3, and Test 3 in period 4.
|
Test 2\Test 1\Test 3\Control
Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 1 in period 2, Test 3 in period 3, and Control in period 4.
|
Control\Test 3\Test 1\Test 2
Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 3 in period 2, Test 1 in period 3, and Test 2 in period 4.
|
Test 3\Test 2\Control\Test 1
Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 2 in period 2, Control in period 3, and 1 Test 1 in period 4.
|
|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Period 3
Subject Unable to Attend V5
|
1
|
0
|
0
|
0
|
|
Period 3
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film
Baseline characteristics by cohort
| Measure |
Total
n=25 Participants
All subjects dispensed a study lens.
|
|---|---|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 7.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post microsphere application over a 30 minute periodPopulation: All subjects who had successfully completed all visits and did not substantially deviate from the protocol
The rate of microsphere clearance from the post-lens tear film was assessed by the C30 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where lens wear was assigned, the microsphere suspension was dispensed onto the posterior concave contact lens surface immediately prior to lens application. A series of digital images were taken over a 30-minute period (every minute for the first 10 minutes and then every 5 minutes for the next 20 minutes). Data transformed from the images were calculated by the C30 image analysis metric. Higher numbers represented greater clearance. The right eye was used to evaluate microsphere clearance.
Outcome measures
| Measure |
Test 1
n=7 eyes
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 2
n=7 eyes
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 3
n=7 eyes
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Control (Bare Eye)
n=7 eyes
Subjects were under the bare eye condition in either the first, second, third, or fourth period of the study.
|
Total
All subjects dispensed a study lens.
|
|---|---|---|---|---|---|
|
Microsphere Clearance Rate
|
96.9 percent clearance
Standard Deviation 1.16
|
98.1 percent clearance
Standard Deviation 2.66
|
99.4 percent clearance
Standard Deviation 3.67
|
96.6 percent clearance
Standard Deviation 2.68
|
—
|
PRIMARY outcome
Timeframe: Post microsphere application over a 10 minute periodPopulation: All subjects who had successfully completed all visits and did not substantially deviate from the protocol
The rate of microsphere uptake into the post-lens tear film was assessed by the U5 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where a lens was assigned the lens was applied and after a 10-minute settling period, a droplet of microsphere suspension was applied directly to the superior temporal conjunctiva. A series of digital images were taken over a 10-minute period (every minute for 10 minutes). Data transformed from the images were calculated by the U5 image analysis metric. Higher numbers represented greater uptake rate. The left eye was used to evaluate microsphere uptake.
Outcome measures
| Measure |
Test 1
n=7 Participants
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 2
n=7 Participants
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 3
n=7 eyes
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Control (Bare Eye)
n=7 eyes
Subjects were under the bare eye condition in either the first, second, third, or fourth period of the study.
|
Total
All subjects dispensed a study lens.
|
|---|---|---|---|---|---|
|
Microsphere Uptake Rate
|
8.5 percent uptake
Standard Deviation 4.09
|
6.8 percent uptake
Standard Deviation 5.31
|
2.9 percent uptake
Standard Deviation 3.35
|
1.5 percent uptake
Standard Deviation 7.62
|
—
|
SECONDARY outcome
Timeframe: Post microsphere application at 30-minute timepoint (OD); post microsphere application at 10-minute timepoint (OS)Population: All subjects dispensed a study lens.
Lens movement was assessed for primary gaze, up-gaze, and push up by clinical grading. Primary gaze movement was evaluated by observing the vertical movement of the contact lens that occurs with a full blink without manipulating the subject's lids. Up-gaze movement was assessed by estimating the vertical lens movement observed when the subject looks up and blinks fully without manipulating the subject's lids. The push-up test consists of a gentle digital push of the lens upwards using the lower lid. The resistance of the lens to of the lens to upward movement is judged. Lens movement was graded according to the following scale: Excessive (+2), Moderate movement (+1), Optimal (0), Minimal (-1), and Insufficient (-2). All available data for lens movement in the safety population were reported.
Outcome measures
| Measure |
Test 1
n=47 eyes
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 2
n=44 eyes
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 3
n=43 eyes
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Control (Bare Eye)
Subjects were under the bare eye condition in either the first, second, third, or fourth period of the study.
|
Total
All subjects dispensed a study lens.
|
|---|---|---|---|---|---|
|
Lens Movement
Primary Position · Insufficient(-2)
|
0 eyes
|
1 eyes
|
2 eyes
|
—
|
—
|
|
Lens Movement
Primary Position · Minimal(-1)
|
12 eyes
|
7 eyes
|
10 eyes
|
—
|
—
|
|
Lens Movement
Primary Position · Optimal(0)
|
28 eyes
|
27 eyes
|
24 eyes
|
—
|
—
|
|
Lens Movement
Primary Position · Moderate(+1)
|
7 eyes
|
9 eyes
|
7 eyes
|
—
|
—
|
|
Lens Movement
Primary Position · Excessive(+2)
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
—
|
|
Lens Movement
Push Up · Insufficient(-2)
|
0 eyes
|
1 eyes
|
1 eyes
|
—
|
—
|
|
Lens Movement
Push Up · Minimal(-1)
|
6 eyes
|
6 eyes
|
2 eyes
|
—
|
—
|
|
Lens Movement
Push Up · Optimal(0)
|
31 eyes
|
30 eyes
|
28 eyes
|
—
|
—
|
|
Lens Movement
Push Up · Moderate(+1)
|
10 eyes
|
7 eyes
|
12 eyes
|
—
|
—
|
|
Lens Movement
Push Up · Excessive(+2)
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
—
|
|
Lens Movement
Up-gaze · Insufficient(-2)
|
0 eyes
|
1 eyes
|
2 eyes
|
—
|
—
|
|
Lens Movement
Up-gaze · Minimal(-1)
|
18 eyes
|
12 eyes
|
9 eyes
|
—
|
—
|
|
Lens Movement
Up-gaze · Optimal(0)
|
22 eyes
|
20 eyes
|
24 eyes
|
—
|
—
|
|
Lens Movement
Up-gaze · Moderate(+1)
|
7 eyes
|
11 eyes
|
8 eyes
|
—
|
—
|
|
Lens Movement
Up-gaze · Excessive(+2)
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: All subjects dispensed a study lens.
Corneal curvature was assessed by Visante™ OCT. The following were measured: Sclera Angle-Temporal and Sclera Angle-Nasal.
Outcome measures
| Measure |
Test 1
n=50 eyes
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 2
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 3
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Control (Bare Eye)
Subjects were under the bare eye condition in either the first, second, third, or fourth period of the study.
|
Total
All subjects dispensed a study lens.
|
|---|---|---|---|---|---|
|
Corneal Curvature
Sclera Angle-Temporal
|
39.14 Degree
Standard Deviation 2.374
|
—
|
—
|
—
|
—
|
|
Corneal Curvature
Sclera Angle-Nasal
|
36.64 Degree
Standard Deviation 3.311
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: All subjects dispensed a study lens.
Corneal curvature was assessed by Visante™ OCT. Sagital Height was measured.
Outcome measures
| Measure |
Test 1
n=50 eyes
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 2
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 3
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Control (Bare Eye)
Subjects were under the bare eye condition in either the first, second, third, or fourth period of the study.
|
Total
All subjects dispensed a study lens.
|
|---|---|---|---|---|---|
|
Corneal Curvature
|
3.700 Millimeter
Standard Deviation 0.1854
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and the 30-minute post microsphere application time point in the right eye and at the 10-minute post microsphere application timepoint in the left eye.Population: All subjects dispensed a study lens.
Blinking characteristics were captured using an infra-red camera (FLIR Grasshopper 3 camera) and infra-red LED illumination (Thorlabs LIU780A). During video capture the subject was directed to view a wildlife video on an Ipad at a working distance of approximately 1 meter. The infrared video was captured for 3 minutes at 500 frames per second. Subsequent video analysis recorded the blink rate (blinks per minute) over the 3-minute period. Baseline values were reported across all subjects who were dispensed a study lens. Blink rate post microsphere application was reported by treatment. All available data for blink rate in the safety population were reported.
Outcome measures
| Measure |
Test 1
n=47 eyes
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 2
n=44 eyes
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 3
n=42 eyes
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Control (Bare Eye)
n=48 eyes
Subjects were under the bare eye condition in either the first, second, third, or fourth period of the study.
|
Total
n=50 eyes
All subjects dispensed a study lens.
|
|---|---|---|---|---|---|
|
Blink Rate
Baseline
|
0 blinks per minute
Standard Deviation 0
|
0 blinks per minute
Standard Deviation 0
|
0 blinks per minute
Standard Deviation 0
|
0 blinks per minute
Standard Deviation 0
|
28.2 blinks per minute
Standard Deviation 16.48
|
|
Blink Rate
Post Lens Insertion
|
23.3 blinks per minute
Standard Deviation 11.63
|
26.1 blinks per minute
Standard Deviation 15.88
|
25.0 blinks per minute
Standard Deviation 13.02
|
19.8 blinks per minute
Standard Deviation 13.08
|
0 blinks per minute
Standard Deviation 0
|
Adverse Events
Test 1
Test 2
Test 3
Control (Bare Eye)
Serious adverse events
| Measure |
Test 1
n=25 participants at risk
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 2
n=25 participants at risk
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Test 3
n=25 participants at risk
Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study
|
Control (Bare Eye)
n=25 participants at risk
Subjects were under bare eye condition in either the first, second, third, or fourth period of the study.
|
|---|---|---|---|---|
|
Eye disorders
Unconfirmed Corneal Endothelium Keratic Precipitate
|
0.00%
0/25 • Throughout the duration of the study. Approximately 13 weeks.
|
4.0%
1/25 • Number of events 1 • Throughout the duration of the study. Approximately 13 weeks.
|
0.00%
0/25 • Throughout the duration of the study. Approximately 13 weeks.
|
0.00%
0/25 • Throughout the duration of the study. Approximately 13 weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
Thomas R. Karkkainen, OD, MS, FAAO
Johnson & Johnson Vision Care, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60