Trial Outcomes & Findings for The Effects of Contact Lenses With Experimental Dye on Visual Function (NCT NCT03556579)
NCT ID: NCT03556579
Last Updated: 2019-11-18
Results Overview
The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.
COMPLETED
NA
62 participants
Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
2019-11-18
Participant Flow
A total of 62 subjects were into this study. Of those enrolled, 60 were assigned and administered a study lens. Two subjects were enrolled but not administered a study lens. All 60 subjects completed the study.
Subjects were stratified into two age groups: 18-39 and 40-65 using a 2:1 allocation. Subjects were randomized at each visit using a contralateral design.
Participant milestones
| Measure |
OD:Test, OS:Control/ OD:Test, OS:Control
Subjects that were randomized to receive the Test lens in their right eye and the Control lens in their left eye at both visit 1 and visit 2.
|
OD:Test, OS:Control/ OD:Control, OS:Test
Subjects that were randomized to receive at visit 1 the Test lens in their right eye and the Control lens in their left eye and at visit 2 was randomized to receive the Control lens in their right eye and the Test lens in their left eye.
|
OD:Control, OS:Test/ OD:Test, OS:Control
Subjects that were randomized to receive at visit 1 the Control lens in their right eye and the Test lens in their left eye and at visit 2 was randomized to receive the Test lens in their right eye and the Control lens in their left eye.
|
OD:Control, OS:Test/ OD:Control, OS:Test
Subjects that were randomized to receive the Control lens in their right eye and the Test lens in their left eye at both visit 1 and visit 2.
|
|---|---|---|---|---|
|
Visit 1
STARTED
|
16
|
14
|
14
|
16
|
|
Visit 1
COMPLETED
|
16
|
14
|
14
|
16
|
|
Visit 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Visit 2
STARTED
|
16
|
14
|
14
|
16
|
|
Visit 2
COMPLETED
|
16
|
14
|
14
|
16
|
|
Visit 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Contact Lenses With Experimental Dye on Visual Function
Baseline characteristics by cohort
| Measure |
Safety Population
n=60 Participants
All Subjects that were Fit with at least one study lens.
|
|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 11.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
22 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
35 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Count of Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2Population: All subjects that completed the study without a major protocol deviation impacting any primary endpoint.
The two-point light spread function was assessed at visit 2 for each subject eye under two conditions with a distance filter and without a distance filter. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Two-point light spread function is defined that the as the minimum distance (mm) that two points of light are completely distinct. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and light source combination was reported across age groups.
Outcome measures
| Measure |
Testing With Additional Light Source
n=54 Eyes
Subjects that wore the Test lens in either eye during visit 2. This lens was measured using an additional light source.
|
Control With Additional Source
n=54 Eyes
Subjects that wore the Control lens in either eye during visit 2. This lens was measured using an additional light source.
|
Test Without Additional Light Source
n=54 Eyes
Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.
|
Control Without Additional Light Source
n=54 Eyes
Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
|
|---|---|---|---|---|
|
Two-Point Light Spread Function
with distance filter
|
5.36 mm
Standard Deviation 3.132
|
6.71 mm
Standard Deviation 2.521
|
6.47 mm
Standard Deviation 3.304
|
7.48 mm
Standard Deviation 3.149
|
|
Two-Point Light Spread Function
Without Dustance Filter
|
2.29 mm
Standard Deviation 1.129
|
3.37 mm
Standard Deviation 1.214
|
3.05 mm
Standard Deviation 1.205
|
3.78 mm
Standard Deviation 1.472
|
PRIMARY outcome
Timeframe: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2Population: All subjects that completed the study without a major protocol deviation impacting any primary endpoint.
The appearance of Halos was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Halos were quantified as the diameter (mm) of the outer edges of the Halo. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.
Outcome measures
| Measure |
Testing With Additional Light Source
n=54 Eyes
Subjects that wore the Test lens in either eye during visit 2. This lens was measured using an additional light source.
|
Control With Additional Source
n=54 Eyes
Subjects that wore the Control lens in either eye during visit 2. This lens was measured using an additional light source.
|
Test Without Additional Light Source
n=54 Eyes
Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.
|
Control Without Additional Light Source
n=54 Eyes
Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
|
|---|---|---|---|---|
|
Halos
|
29.20 mm
Standard Deviation 15.777
|
52.57 mm
Standard Deviation 22.758
|
39.09 mm
Standard Deviation 14.524
|
46.73 mm
Standard Deviation 18.355
|
PRIMARY outcome
Timeframe: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2Population: Subjects that have completed all study visits without a major protocol deviation impacting a primary endpoint.
The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.
Outcome measures
| Measure |
Testing With Additional Light Source
n=54 eyes
Subjects that wore the Test lens in either eye during visit 2. This lens was measured using an additional light source.
|
Control With Additional Source
n=54 eyes
Subjects that wore the Control lens in either eye during visit 2. This lens was measured using an additional light source.
|
Test Without Additional Light Source
n=54 eyes
Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.
|
Control Without Additional Light Source
n=54 eyes
Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
|
|---|---|---|---|---|
|
Starburts
|
45.66 mm
Standard Deviation 24.228
|
75.12 mm
Standard Deviation 27.370
|
55.78 mm
Standard Deviation 23.037
|
69.60 mm
Standard Deviation 25.914
|
SECONDARY outcome
Timeframe: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1Population: All subjects that completed the study without a major protocol deviation impacting any primary endpoint.
The Glare disability threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported across age groups.
Outcome measures
| Measure |
Testing With Additional Light Source
n=54 eyes
Subjects that wore the Test lens in either eye during visit 2. This lens was measured using an additional light source.
|
Control With Additional Source
n=54 eyes
Subjects that wore the Control lens in either eye during visit 2. This lens was measured using an additional light source.
|
Test Without Additional Light Source
Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.
|
Control Without Additional Light Source
Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
|
|---|---|---|---|---|
|
Glare Disability Threshold
|
0.98 log units
Standard Deviation 0.166
|
1.16 log units
Standard Deviation 0.140
|
—
|
—
|
SECONDARY outcome
Timeframe: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1Population: Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.
Photostress Recovery (PR) Time (seconds) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects are exposed to a target, once the target was able to be comfortable viewed by the subject, a bright bleaching light covered it. As the afterimage fades, participants will gradually be able to re-gain sight of the target. PR time will be recorded as the time it takes following exposure to the bleaching light to regain sight of the target. PR Times are positive values where smaller times indicate better lens performance. The average PR Time (seconds) for each lens type was reported across age groups.
Outcome measures
| Measure |
Testing With Additional Light Source
n=54 eyes
Subjects that wore the Test lens in either eye during visit 2. This lens was measured using an additional light source.
|
Control With Additional Source
n=54 eyes
Subjects that wore the Control lens in either eye during visit 2. This lens was measured using an additional light source.
|
Test Without Additional Light Source
Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.
|
Control Without Additional Light Source
Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
|
|---|---|---|---|---|
|
Photostress Recovery Time
|
8.83 seconds
Standard Deviation 8.668
|
17.28 seconds
Standard Deviation 15.230
|
—
|
—
|
SECONDARY outcome
Timeframe: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1Population: Subjects that completed all study visits wihtout a major protocol deviation impacting a primary endpoint.
The Glare discomfort (change in palpebral fissure height) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported across age groups.
Outcome measures
| Measure |
Testing With Additional Light Source
n=54 eyes
Subjects that wore the Test lens in either eye during visit 2. This lens was measured using an additional light source.
|
Control With Additional Source
n=54 eyes
Subjects that wore the Control lens in either eye during visit 2. This lens was measured using an additional light source.
|
Test Without Additional Light Source
Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.
|
Control Without Additional Light Source
Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
|
|---|---|---|---|---|
|
Glare Discomfort
|
2.26 mm
Standard Deviation 1.249
|
2.90 mm
Standard Deviation 1.569
|
—
|
—
|
SECONDARY outcome
Timeframe: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1Population: Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.
Heterochromatic Contrast Threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Heterochromatic contrast thresholds are measured as thresholds to a variable wavelength central target presented on a short-wave (460nm) sky-light background. Thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported across age groups.
Outcome measures
| Measure |
Testing With Additional Light Source
n=54 eyes
Subjects that wore the Test lens in either eye during visit 2. This lens was measured using an additional light source.
|
Control With Additional Source
n=54 eyes
Subjects that wore the Control lens in either eye during visit 2. This lens was measured using an additional light source.
|
Test Without Additional Light Source
Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.
|
Control Without Additional Light Source
Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
|
|---|---|---|---|---|
|
Heterochromatic Contrast Threshold
|
1.01 log units
Standard Deviation 0.170
|
1.24 log units
Standard Deviation 0.164
|
—
|
—
|
Adverse Events
Test
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John Buch, O.D. 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