Adults 20 to 49, any sex, with Visual Performance. 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.
Overall Nighttime Driving ScorePrimary· 15 Minutes Post Lens Fitting
Overall driving performance score is a composite score calculated as the mean of the Z-scores of the following six driving measures: average sign recognition distance (in meters), percentage of correctly identified sign (\~42 signs), percentage of hazard avoidance/detection (9 hazards), average pedestrian recognition distance (in meters), lane keeping (percentage of time inside the lane) and the inverse of driving lap time (in seconds).). Equal weighting was assigned to each measure. The individual Z scores were transformed (inverted) such that positive Z scores relate to better performance th
Group
Value
95% CI
Test
-0.308
± 0.4718
Control 1
-0.375
± 0.4361
Control 2
-0.430
± 0.4761
Binocular Visual AcuitySecondary· 15 Minutes Post Lens Fitting
Binocular visual acuity was assessed under Low luminance (\~1 lux) high contrast (90%) conditions at a distance of 4 meters. The ETDRS logMAR chart were used, which is scored on a letter by letter basis (-0.02 log units per letter correctly identified). A number of different EDTRS charts was used to reduce potential learning effects. The average LogMAR acuity for each lens was reported.
Group
Value
95% CI
Test
0.251
± 0.0722
Control 1
0.273
± 0.0705
Control 2
0.298
± 0.0739
Binocular Contrast Threshold Without GlareSecondary· 15 Minutes Post Lens Fitting
Binocular contrast sensitivity was assessed under low luminance conditions. Five Landolt C targets in random orientation were presented for each of the four contrast levels 95%, 80%, 63% and 50%. Participants were asked to correctly identify the orientation of the Landolt C. The percentage of subjects that were able to correct identify the orientation of all 5 Landolt's C was reported for each lens type.
95% Contrast
Group
Value
95% CI
Test
100
Control 1
100
Control 2
100
80% Contrast
Group
Value
95% CI
Test
100
Control 1
95.8
Control 2
95.8
63% Contrast
Group
Value
95% CI
Test
91.7
Control 1
91.7
Control 2
87.5
50%
Group
Value
95% CI
Test
87.5
Control 1
75.0
Control 2
58.3
Percentage of Road Signs Correctly Identified During Night DrivingSecondary· 15 Minutes Post Lens Fitting
Participants were instructed to report the identity of a percentage of the standard road signs (typically about 42 signs dependent on the route travelled) containing about 65 items of information as they drove around the circuit. The percentage of correctly identified signs was reported for each study lens.
Group
Value
95% CI
Test
72.7
Control 1
73.3
Control 2
73.3
Average Distance to Correctly Identify Road Signs During Night DrivingSecondary· 15 Minutes Post Lens Fitting
Measure Description The distance (measured in meters) to recognize a pre-determined road sign was recorded for each subject and lens type at either visit 3 or visit 4, using the in-vehicle measurement system while the participant was driving. The in-vehicle measurement system consisted of a subject pressing a button once the subject was able to recognize the road sign. The average distance in meters was reported for each lens type. Larger distance indicate that a subject was able to identify the pre-determined road sign sooner.
Group
Value
95% CI
Test
110.3
± 23.45
Control 1
101.5
± 25.53
Control 2
95.0
± 22.83
Percentage of Hazards Avoided During Night DrivingSecondary· 15 Minutes Post Lens Fitting
Participants were required to report and avoid hitting any of nine large, low contrast grey foam "hazards" (220 cm x 80 cm x 15 cm) positioned orthogonally in the driving lane along the roadway, the locations of which will be randomized between study lenses. The percentage of Hazards avoided for each study lens was reported.
Group
Value
95% CI
Test
95.4
Control 1
95.4
Control 2
93.1
Average Pedestrian Recognition DistanceSecondary· 15 Minutes Post Lens Fitting
The in-vehicle measurement system was utilized to determine the distance at which the participant (as a driver) first recognizes the presence of two pedestrians positioned at the side of the road. An experimenter acted as the pedestrian and "walked in-place" at the end of a 400 m straight section of roadway which starts and finishes at approximately the same elevation, but features a dip halfway along its length. The pedestrian was not surrounded by any visual clutter or lighting. To reduce expectancy effects, a series of four flashing LEDs and four retro-reflective bollards was positioned aro
Group
Value
95% CI
Test
208.3
± 60.46
Control 1
201.1
± 62.92
Control 2
195.5
± 60.70
Sponsor's own description
This is a bilateral, non-dispensing, randomized, subject masked, four visits, 3-period by 3- treatment crossover study. The objective of this study is to evaluate the effect of JJVC senofilcon A - based contact lens with new UV-blocker on vision and driving performance in both daytime and nighttime lighting under real world driving conditions. This will be achieved through field-based driving studies on a closed-road driving circuit at night and during the day. Quantitative methods will be used to assess vision and driving performance under a range of challenging conditions and appropriate masking, order of testing, randomization and control conditions will be used.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
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: 7 August 2018
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/NCT03330275.