Adults 40 to 70, any sex, with Visual Acuity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Starburst Diameter (mm)Primary· 30-minutes post lens insertion
The starburst diameter (mm) was measured each subject binocularly. Starburst diameter was quantified by the horizontal spread of the spokes emerging from the center of a small, point-like stimulus. A calibrated custom-made micrometer (two sides with reverse threading) was used to spread two posts out from a central mid-point. The posts attach to a custom-designed ruler that indicates the lateral spread of the starburst. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type was reported by period.
Period 1
Group
Value
95% CI
Senofilcon A
77.06
± 25.900
Senofilcon A (C3)
64.13
± 27.703
Period 2
Group
Value
95% CI
Senofilcon A
67.26
± 30.991
Senofilcon A (C3)
54.24
± 22.706
Halos Diameter (mm)Primary· 30-minutes post lens insertion
Halo diameter (mm) was quantified and measured using the same micrometer as for starbursts diameter (mm). The Halo diameter (mm) was measured each subject binocularly. Measurements for halo diameter are positive, where smaller values indicate better performance. The average diameter (mm) for each lens type.
Group
Value
95% CI
Senofilcon A
69.24
± 19.033
Senofilcon A (C3)
52.93
± 17.725
Glare Disability ThresholdPrimary· 30-minutes post lens insertion
Glare disability threshold was collected binocularly for each subject. 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)
Group
Value
95% CI
Senofilcon A
2.62
± 0.235
Senofilcon A (C3)
2.86
± 0.179
Glare Discomfort (mm)Secondary· 30-minutes post lens insertion
The Glare discomfort was evaluated by calculating the change in height of the palpebral fissure measured while the participant views the mid-wave central grating target, compared to the maximal squint during a 5-second Photostress exposure induced by a solid, 10-degree broadband field, which completely obscures the target (\~10-deg diameter). Both eyes were recorded and averaged, to produce an average palpebral fissure height before and during the Photostress exposure. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average
Group
Value
95% CI
Senofilcon A
9.88
± 4.164
Senofilcon A (C3)
6.61
± 3.151
Heterochromatic Contrast Threshold (HCT)Secondary· 30-minutes post lens insertion
Using the same optical bench set-up described Glare Disability Threshold, to measure HCT, participants viewed the mid-wave (580 nm) grating target presented on presented on a short wave (460 nm) "sky-light background." The intensity of the background was adjusted, until the participant was no longer able to resolve the grating target. The log relative energy of the background needed to obscure the central target was recorded as HCT. Heterochromatic contrast thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported.
Group
Value
95% CI
Senofilcon A
1.85
± 0.221
Senofilcon A (C3)
2.14
± 0.295
Two-Point Threshold (mm) With 403nm FilterSecondary· 30-minutes post lens insertion
To create the two-point threshold stimulus, a single point- source like stimulus was spread into two distinct points of light, using a custom-built, collapsible light baffle. The two-point threshold was quantified as the minimum distance (mm) at which a participant could detect two distinct points of light, separated by a small black space. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and period.
Period 1
Group
Value
95% CI
Senofilcon A
16.49
± 5.600
Senofilcon A (C3)
7.51
± 2.889
Period 2
Group
Value
95% CI
Senofilcon A
13.21
± 5.021
Senofilcon A (C3)
9.50
± 6.321
Two-Point Threshold (mm) Without 403nm FilterSecondary· 30-minutes post lens insertion
To create the two-point threshold stimulus, a single point- source like stimulus was spread into two distinct points of light, using a custom-built, collapsible light baffle. The two-point threshold was quantified as the minimum distance (mm) at which a participant could detect two distinct points of light, separated by a small black space. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type.
Group
Value
95% CI
Senofilcon A
8.63
± 3.391
Senofilcon A (C3)
5.47
± 1.953
Sponsor's own description
This is a single-masked, bilateral, controlled, randomized, 2x2 crossover, non-dispensing clinical trial to characterize the effects of an HEV-Blocker on several measures of visual function in a presbyopic population.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Vision Care, Inc.
Last refreshed: 6 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04995055.