Trial Outcomes & Findings for Visual Performance of Senofilcon A With and Without a New UV/HEV-filter (NCT NCT05021081)
NCT ID: NCT05021081
Last Updated: 2023-01-26
Results Overview
Photopic (\~120 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.
COMPLETED
NA
82 participants
Post screening up to 1 hour during Phase 1
2023-01-26
Participant Flow
In Phase I, 20 subjects were enrolled and completed this Phase. In Phase 2, 62 subjects were enrolled. Of those enrolled in Phase 2, all 62 were dispensed at least 1 study lens. Of those dispensed, 60 subjects completed Phase 2 while 2 subjects were discontinued from Phase 2. Phase I and Phase II are mutually exclusive. Data collected from Phase I was used to validate the glare light source for evaluating the primary and secondary endpoints in Phase II.
Unit of analysis: Eyes
Participant milestones
| Measure |
OD: Test (Senofilcon A C3) /OS: Control (Senofilcon A C3) (Phase 2)
Subjects randomized to this sequence received the Test lens on the right eye and received the Control lens on the left eye
|
OD: Control (Senofilcon A C3) / OS: Test (Senofilcon A C3) (Phase 2)
Subjects randomized to this sequence received the Control lens on the right eye and received the Test lens on the left eye
|
Subjects' Own Contact Lens (Phase 1)
Subjects enrolled into this phase used the following marketed contact lenses: senofilcon A (1-Day), senofilcon A (2-week reusable), senofilcon A C3, lotrafilcon B, comifilcon A, somofilcon A, delefilcon A, and stenfilcon A
|
|---|---|---|---|
|
Phase 1
STARTED
|
0 0
|
0 0
|
20 40
|
|
Phase 1
COMPLETED
|
0 0
|
0 0
|
20 40
|
|
Phase 1
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Phase 2
STARTED
|
31 62
|
31 62
|
0 0
|
|
Phase 2
COMPLETED
|
30 60
|
30 60
|
0 0
|
|
Phase 2
NOT COMPLETED
|
1 2
|
1 2
|
0 0
|
Reasons for withdrawal
| Measure |
OD: Test (Senofilcon A C3) /OS: Control (Senofilcon A C3) (Phase 2)
Subjects randomized to this sequence received the Test lens on the right eye and received the Control lens on the left eye
|
OD: Control (Senofilcon A C3) / OS: Test (Senofilcon A C3) (Phase 2)
Subjects randomized to this sequence received the Control lens on the right eye and received the Test lens on the left eye
|
Subjects' Own Contact Lens (Phase 1)
Subjects enrolled into this phase used the following marketed contact lenses: senofilcon A (1-Day), senofilcon A (2-week reusable), senofilcon A C3, lotrafilcon B, comifilcon A, somofilcon A, delefilcon A, and stenfilcon A
|
|---|---|---|---|
|
Phase 2
Subject enrolled in error
|
1
|
1
|
0
|
Baseline Characteristics
Visual Performance of Senofilcon A With and Without a New UV/HEV-filter
Baseline characteristics by cohort
| Measure |
Phase 1
n=20 Participants
Phase 1 was a non-randomized design where subjects wore their own contact lenses
|
Phase 2
n=62 Participants
Phase 2 was a randomized design with two test articles
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.7 years
STANDARD_DEVIATION 5.62 • n=99 Participants
|
38.6 years
STANDARD_DEVIATION 14.07 • n=107 Participants
|
35.2 years
STANDARD_DEVIATION 13.88 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Post screening up to 1 hour during Phase 1Population: All subjects that completed Phase 1 without a major protocol deviation excluding subjects recording an increase in photopic contrast sensitivity with the glare source.
Photopic (\~120 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.
Outcome measures
| Measure |
With Glare
n=15 Eyes
Subjects with photopic contrast sensitivity measured with a broadband glare source during Phase 1.
|
Without Glare
n=15 Eyes
Subject with photopic contrast sensitivity measured without a broadband glare source during Phase 1.
|
|---|---|---|
|
Photopic Contrast Sensitivity at 6 Cpd
|
1.46 Log Unit
Standard Deviation 0.317
|
1.91 Log Unit
Standard Deviation 0.373
|
PRIMARY outcome
Timeframe: Post screening up to 1 hour during Phase 1Population: All subjects completed Phase 1 without a major protocol deviation excluding subjects recording an increase in mesopic contrast sensitivity with the glare source.
Mesopic (\~3 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.
Outcome measures
| Measure |
With Glare
n=14 Eyes
Subjects with photopic contrast sensitivity measured with a broadband glare source during Phase 1.
|
Without Glare
n=14 Eyes
Subject with photopic contrast sensitivity measured without a broadband glare source during Phase 1.
|
|---|---|---|
|
Mesopic Contrast Sensitivity at 6 Cpd
|
0.70 Log Unit
Standard Deviation 0.328
|
1.29 Log Unit
Standard Deviation 0.498
|
PRIMARY outcome
Timeframe: At least 5 minutes post lens fitting up to 2 hours during Phase 2Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
Photopic resolution acuity using Landolt C's was measured separately for the right (OD) and left (OS) eyes, using an arcminute scale under bright light conditions (\~120 cd/m2) with a broadband glare source. The photopic resolution acuity on arcminute scale was converted to logMAR scale for the analysis purpose using a log transformation. Lower values indicate better acuity.
Outcome measures
| Measure |
With Glare
n=62 Eyes
Subjects with photopic contrast sensitivity measured with a broadband glare source during Phase 1.
|
Without Glare
n=62 Eyes
Subject with photopic contrast sensitivity measured without a broadband glare source during Phase 1.
|
|---|---|---|
|
Photopic Resolution Acuity Using Landolt C's With a Glare Source
|
0.01 logMAR
Standard Deviation 0.191
|
-0.01 logMAR
Standard Deviation 0.158
|
SECONDARY outcome
Timeframe: At least 5 minutes post lens fitting up to 2 hours during Phase 2Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
Photopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under bright light conditions (\~120 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity.
Outcome measures
| Measure |
With Glare
n=62 Eyes
Subjects with photopic contrast sensitivity measured with a broadband glare source during Phase 1.
|
Without Glare
n=62 Eyes
Subject with photopic contrast sensitivity measured without a broadband glare source during Phase 1.
|
|---|---|---|
|
Photopic Contrast Sensitivity With a Glare Source
|
1.18 Units on a scale
Standard Deviation 0.248
|
1.21 Units on a scale
Standard Deviation 0.250
|
SECONDARY outcome
Timeframe: At least 5 minutes post lens fitting up to 2 hours during Phase 2Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
Mesopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under dim light conditions (less than or equal 3 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity.
Outcome measures
| Measure |
With Glare
n=62 Eyes
Subjects with photopic contrast sensitivity measured with a broadband glare source during Phase 1.
|
Without Glare
n=62 Eyes
Subject with photopic contrast sensitivity measured without a broadband glare source during Phase 1.
|
|---|---|---|
|
Mesopic Contrast Sensitivity With a Glare Source
|
0.71 Units on a scale
Standard Deviation 0.212
|
0.72 Units on a scale
Standard Deviation 0.232
|
Adverse Events
Phase 1 - Senofilcon A (1-Day)
Phase 1 - Senofilcon A (2-week Reusable)
Phase 1 - Senofilcon A C3
Phase 1 - Lotrafilcon B
Phase 1 - Comifilcon A
Phase 1 - Somofilcon A
Phase 1 -Delefilcon A
Phase 1 -Stenfilcon A
Phase 2 - Control (Senofilcon A C3)
Phase 2 - Test (Senofilcon A C3)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John R. Buch, O.D., M.S., F.A.A.O.
Johnson & Johnson Vision Care, Inc. (JJVC)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60