Trial Outcomes & Findings for Role of Glare and Spectral Filtering on Contrast Sensitivity: A Pilot Study (NCT NCT05582304)
NCT ID: NCT05582304
Last Updated: 2024-01-31
Results Overview
Photopic contrast sensitivity was measured under bright light conditions (\~120 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)\*log(cpd).
COMPLETED
NA
40 participants
Up to 2 hours post-fitting
2024-01-31
Participant Flow
This was a split-plot design with two parallel arms consisting of two randomized lighting conditions (photopic and mesopic). Within each parallel arm, subjects were further randomized in a contralateral fashion to the Test and Control lenses. A total of 40 subjects were enrolled and completed the study.
Participant milestones
| Measure |
Photopic: OD: Test (Senofilcon A C3) / OS: Control (Senofilcon A C3)
Subjects randomized to this condition arm and lens sequence received the Test lens on the right eye and received the Control lens on the left eye under the photopic condition.
|
Photopic: OD: Control (Senofilcon A C3) / OS: Test (Senofilcon A C3)
Subjects randomized to this condition arm and lens sequence received the Control lens on the right eye and received the Test lens on the left eye under the photopic condition.
|
Mesopic: OD: Test (Senofilcon A C3) / OS: Control (Senofilcon A C3)
Subjects randomized to this condition arm and lens sequence received the Test lens on the right eye and received the Control lens on the left eye under the mesopic condition.
|
Mesopic: OD: Control (Senofilcon A C3) / OS: Test (Senofilcon A C3)
Subjects randomized to this condition arm and lens sequence received the Control lens on the right eye and received the Test lens on the left eye under the mesopic condition
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
11
|
9
|
|
Overall Study
COMPLETED
|
9
|
11
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Role of Glare and Spectral Filtering on Contrast Sensitivity: A Pilot Study
Baseline characteristics by cohort
| Measure |
Photopic
n=20 Participants
Subjects assigned bright light conditions (\~120 cd/m2).
|
Mesopic
n=20 Participants
Subjects assigned dim light conditions (\~3cd/m2).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 14.14 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 13.95 • n=7 Participants
|
37.4 years
STANDARD_DEVIATION 13.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 hours post-fittingPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
Photopic contrast sensitivity was measured under bright light conditions (\~120 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)\*log(cpd).
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=20 eyes
Subject eyes that wore the Test lens during the study.
|
Control (Senofilcon A C3)
n=20 eyes
Subject eyes that wore the Control lens during the study.
|
|---|---|---|
|
Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source
|
1.92 log(sensitivity)*log(cpd)
Standard Deviation 0.220
|
1.62 log(sensitivity)*log(cpd)
Standard Deviation 0.158
|
SECONDARY outcome
Timeframe: Up to 2 hours post-fittingPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
Mesopic contrast sensitivity was measured under dim light conditions (\~3 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)\*log(cpd).
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=20 eyes
Subject eyes that wore the Test lens during the study.
|
Control (Senofilcon A C3)
n=20 eyes
Subject eyes that wore the Control lens during the study.
|
|---|---|---|
|
Area Under the Curve of Mesopic Contrast Sensitivity Under Dim Light Conditions (∼3 cd/m2) With a Broadband Glare Source.
|
0.57 log(sensitivity)*log(cpd)
Standard Deviation 0.189
|
0.43 log(sensitivity)*log(cpd)
Standard Deviation 0.140
|
Adverse Events
Test (Senofilcon A C3)
Control (Senofilcon A C3)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John R Buch
Johnson & Johnson Vision Care, Inc. (JJVC)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60