Trial Outcomes & Findings for The Effects of Contact Lenses With UV/HEV-Filter on Visual Function (NCT NCT05601544)
NCT ID: NCT05601544
Last Updated: 2025-04-27
Results Overview
Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target. Better visual range is indicated by a higher log-relative energy (LRE) of simulated haze (more haze) to obscure an otherwise highly visible target.
COMPLETED
NA
145 participants
Approximately 15 minutes post lens fitting
2025-04-27
Participant Flow
21 subjects (only sphere and multifocal subjects) were enrolled into Phase 1 of this study and 0 subjects failed to meet all eligibility criteria. All 21 subjects were dispensed at least 1 study lens and completed Phase 1. 124 subjects were enrolled into Phase 2. Of those enrolled into Phase 2, 121 subjects were dispensed at least 2 study lenses, while 3 subjects failed to meet all eligibility criteria. 120 subjects completed and 1 subject discontinued from the study during Phase 2.
Participant milestones
| Measure |
Senofilcon A (Test) / Senofilcon A (Control) Sphere Strata
Subjects randomized to this sequence are spherical contact lens wearers that received the Test lens during the first period and then received the Control lens during the second period
|
Senofilcon A (Control)/ Senofilcon A (Test) Sphere Strata
Subjects randomized to this sequence are spherical contact lens wearers that received the Control lens during the first period and then received the Test lens during the second period
|
Senofilcon A (Test) / Senofilcon A (Control) Multifocal Strata
Subjects randomized to this sequence are multifocal contact lens wearers that received the Test lens during the first period and then received the Control lens during the second period
|
Senofilcon A (Control) / Senofilcon A (Test) Multifocal Strata
Subjects randomized to this sequence are multifocal contact lens wearers that received the Control lens during the first period and then received the Test lens during the second period
|
Senofilcon A (Test) / Senofilcon A (Control) Toric Strata
Subjects randomized to this sequence are toric contact lens wearers that received the Test lens during the first period and then received the Control lens during the second period
|
Senofilcon A (Control) / Senofilcon A (Control) Toric Strata
Subjects randomized to this sequence are toric contact lens wearers that received the Control lens during the first period and then received the Control lens during the second period
|
|---|---|---|---|---|---|---|
|
Phase 1 Period 1
STARTED
|
5
|
6
|
5
|
5
|
0
|
0
|
|
Phase 1 Period 1
COMPLETED
|
5
|
6
|
5
|
5
|
0
|
0
|
|
Phase 1 Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Period 2
STARTED
|
5
|
6
|
5
|
5
|
0
|
0
|
|
Phase 1 Period 2
COMPLETED
|
5
|
6
|
5
|
5
|
0
|
0
|
|
Phase 1 Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Period 1
STARTED
|
20
|
21
|
20
|
20
|
20
|
20
|
|
Phase 2 Period 1
COMPLETED
|
20
|
20
|
20
|
20
|
20
|
20
|
|
Phase 2 Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase 2 Period 2
STARTED
|
20
|
20
|
20
|
20
|
20
|
20
|
|
Phase 2 Period 2
COMPLETED
|
20
|
20
|
20
|
20
|
20
|
20
|
|
Phase 2 Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Senofilcon A (Test) / Senofilcon A (Control) Sphere Strata
Subjects randomized to this sequence are spherical contact lens wearers that received the Test lens during the first period and then received the Control lens during the second period
|
Senofilcon A (Control)/ Senofilcon A (Test) Sphere Strata
Subjects randomized to this sequence are spherical contact lens wearers that received the Control lens during the first period and then received the Test lens during the second period
|
Senofilcon A (Test) / Senofilcon A (Control) Multifocal Strata
Subjects randomized to this sequence are multifocal contact lens wearers that received the Test lens during the first period and then received the Control lens during the second period
|
Senofilcon A (Control) / Senofilcon A (Test) Multifocal Strata
Subjects randomized to this sequence are multifocal contact lens wearers that received the Control lens during the first period and then received the Test lens during the second period
|
Senofilcon A (Test) / Senofilcon A (Control) Toric Strata
Subjects randomized to this sequence are toric contact lens wearers that received the Test lens during the first period and then received the Control lens during the second period
|
Senofilcon A (Control) / Senofilcon A (Control) Toric Strata
Subjects randomized to this sequence are toric contact lens wearers that received the Control lens during the first period and then received the Control lens during the second period
|
|---|---|---|---|---|---|---|
|
Phase 2 Period 1
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
All subjects dispensed a study lens in Phase 1
Baseline characteristics by cohort
| Measure |
Sphere Strata - Phase 1
n=11 Participants
Subjects who are spherical contact lens wearers
|
Multifocal Strata - Phase 1
n=10 Participants
Subjects who are multifocal contact lens wearers
|
Sphere Strata - Phase2
n=41 Participants
Subjects who are spherical contact lens wearers
|
Multifocal Strata - Phase 2
n=40 Participants
Subjects who are multifocal contact lens wearers
|
Toric Strata - Phase 2
n=40 Participants
Subjects who are toric contact lens wearers
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
114 Participants
n=8 Participants
|
|
Age, Continuous
|
23.4 Years
STANDARD_DEVIATION 3.04 • n=5 Participants • All subjects dispensed a study lens in Phase 1
|
50.9 Years
STANDARD_DEVIATION 9.88 • n=7 Participants • All subjects dispensed a study lens in Phase 1
|
25.8 Years
STANDARD_DEVIATION 6.49 • n=5 Participants • All subjects dispensed a study lens in Phase 1
|
51.0 Years
STANDARD_DEVIATION 7.08 • n=4 Participants • All subjects dispensed a study lens in Phase 1
|
24.9 Years
STANDARD_DEVIATION 5.28 • n=21 Participants • All subjects dispensed a study lens in Phase 1
|
36.5 Years
STANDARD_DEVIATION 15.72 • n=8 Participants • All subjects dispensed a study lens in Phase 1
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
117 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
142 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Approximately 15 minutes post lens fittingPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target. Better visual range is indicated by a higher log-relative energy (LRE) of simulated haze (more haze) to obscure an otherwise highly visible target.
Outcome measures
| Measure |
Senofilcon A (Test) Sphere Strata - Phase 1
n=11 Participants
Spherical subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study.
|
Senofilcon A (Control) Sphere Strata - Phase 1
n=11 Participants
Spherical subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study
|
Senofilcon A (Test) Multifocal Strata - Phase 1
n=10 Participants
Multifocal subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study
|
Senofilcon A (Control) Multifocal Strata - Phase 1
n=10 Participants
Multifocal subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study
|
|---|---|---|---|---|
|
Visual Range at Phase 1
|
3.232 log relative energy level
Standard Deviation 0.1658
|
3.049 log relative energy level
Standard Deviation 0.2101
|
3.287 log relative energy level
Standard Deviation 0.1824
|
3.167 log relative energy level
Standard Deviation 0.1072
|
PRIMARY outcome
Timeframe: Approximately 15 minutes post lens fittingPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. Based on the pre-specified primary analyses for Phase 2, the primary hypothesis testing was performed for Sphere and Multifocal strata only.
Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target. Better visual range is indicated by a higher log-relative energy (LRE) of simulated haze (more haze) to obscure an otherwise highly visible target.
Outcome measures
| Measure |
Senofilcon A (Test) Sphere Strata - Phase 1
n=40 Participants
Spherical subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study.
|
Senofilcon A (Control) Sphere Strata - Phase 1
n=41 Participants
Spherical subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study
|
Senofilcon A (Test) Multifocal Strata - Phase 1
n=40 Participants
Multifocal subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study
|
Senofilcon A (Control) Multifocal Strata - Phase 1
n=40 Participants
Multifocal subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study
|
|---|---|---|---|---|
|
Visual Range at Phase 2
|
3.377 log relative energy level
Standard Deviation 0.1489
|
3.156 log relative energy level
Standard Deviation 0.1181
|
3.181 log relative energy level
Standard Deviation 0.1649
|
3.020 log relative energy level
Standard Deviation 0.1412
|
PRIMARY outcome
Timeframe: Approximately 15 minutes post lens fittingPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. Subject were analyzed per planned randomized treatment.
Motion detection is defined as the distance needed (in mm) to determine that a test light has moved from a standard position. Better motion detection is indicated by a smaller distance needed to detect that movement has occurred.
Outcome measures
| Measure |
Senofilcon A (Test) Sphere Strata - Phase 1
n=11 Participants
Spherical subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study.
|
Senofilcon A (Control) Sphere Strata - Phase 1
n=11 Participants
Spherical subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study
|
Senofilcon A (Test) Multifocal Strata - Phase 1
n=10 Participants
Multifocal subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study
|
Senofilcon A (Control) Multifocal Strata - Phase 1
n=10 Participants
Multifocal subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study
|
|---|---|---|---|---|
|
Motion Detection at Phase 1
|
1.725 mm
Standard Deviation 1.3575
|
2.881 mm
Standard Deviation 1.9824
|
3.229 mm
Standard Deviation 2.3248
|
2.716 mm
Standard Deviation 3.1286
|
PRIMARY outcome
Timeframe: Approximately 15 minutes post lens fittingPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. Subject were analyzed per planned randomized treatment.
Brightness perception is defined as the log- relative energy needed to match a standard stimulus to a natural scene, across 10 different projected scenes. The perception of brighter image is indicated by a higher log-relative energy (LRE) needed to match the initially dim standard to the target.
Outcome measures
| Measure |
Senofilcon A (Test) Sphere Strata - Phase 1
n=11 Participants
Spherical subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study.
|
Senofilcon A (Control) Sphere Strata - Phase 1
n=11 Participants
Spherical subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study
|
Senofilcon A (Test) Multifocal Strata - Phase 1
n=10 Participants
Multifocal subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study
|
Senofilcon A (Control) Multifocal Strata - Phase 1
n=10 Participants
Multifocal subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study
|
|---|---|---|---|---|
|
Brightness Perception at Phase 1
|
1.109 log relative energy
Standard Deviation 0.0909
|
1.081 log relative energy
Standard Deviation 0.1494
|
1.101 log relative energy
Standard Deviation 0.1388
|
1.041 log relative energy
Standard Deviation 0.2222
|
SECONDARY outcome
Timeframe: Approximately 15 minutes post lens fittingPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. Subject were analyzed per planned randomized treatment. Based on the pre-specified primary analyses for Phase 2, the primary hypothesis testing was performed for Sphere and Multifocal strata only.
Motion detection is defined as the distance needed (in mm) to determine that a test light has moved from a standard position. Better motion detection is indicated by a smaller distance needed to detect that movement has occurred.
Outcome measures
| Measure |
Senofilcon A (Test) Sphere Strata - Phase 1
n=40 Participants
Spherical subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study.
|
Senofilcon A (Control) Sphere Strata - Phase 1
n=41 Participants
Spherical subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study
|
Senofilcon A (Test) Multifocal Strata - Phase 1
n=39 Participants
Multifocal subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study
|
Senofilcon A (Control) Multifocal Strata - Phase 1
n=39 Participants
Multifocal subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study
|
|---|---|---|---|---|
|
Motion Detection at Phase 2
|
3.894 mm
Standard Deviation 2.6800
|
4.288 mm
Standard Deviation 2.9575
|
3.499 mm
Standard Deviation 2.4146
|
3.3376 mm
Standard Deviation 2.3750
|
SECONDARY outcome
Timeframe: Approximately 15 minutes post lens fittingPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. Subject were analyzed per planned randomized treatment. Based on the pre-specified primary analyses for Phase 2, the primary hypothesis testing was performed for Sphere and Multifocal strata only.
Brightness perception is defined as the log- relative energy needed to match a standard stimulus to a natural scene, across 10 different projected scenes. The perception of brighter image is indicated by a higher log-relative energy (LRE) needed to match the initially dim standard to the target.
Outcome measures
| Measure |
Senofilcon A (Test) Sphere Strata - Phase 1
n=40 Participants
Spherical subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study.
|
Senofilcon A (Control) Sphere Strata - Phase 1
n=40 Participants
Spherical subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study
|
Senofilcon A (Test) Multifocal Strata - Phase 1
n=40 Participants
Multifocal subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study
|
Senofilcon A (Control) Multifocal Strata - Phase 1
n=40 Participants
Multifocal subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study
|
|---|---|---|---|---|
|
Brightness Perception at Phase 2
|
1.356 log relative energy
Standard Deviation 0.0670
|
1.222 log relative energy
Standard Deviation 0.0615
|
1.360 log relative energy
Standard Deviation 0.0832
|
1.219 log relative energy
Standard Deviation 0.0843
|
Adverse Events
Senofilcon A (Test) Sphere Strata - Phase 1
Senofilcon A (Control) Sphere Strata - Phase 1
Senofilcon A (Test) Multifocal Strata - Phase 1
Senofilcon A (Control) Multifocal Strata - Phase 1
Senofilcon A (Test) Sphere Strata - Phase 2
Senofilcon A (Control) Sphere Strata - Phase 2
Senofilcon A (Test) Multifocal Strata - Phase 2
Senofilcon A (Control) Multifocal Strata - Phase 2
Senofilcon A (Test) Toric Strata - Phase 2
Senofilcon A (Control) Toric Strata - Phase 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Principal Research Optometrist
Johnson & Johnson Vision Care, Inc. (JJVC)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60