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Evaluating the Impact of JJVC Senofilcon A - Based Contact Lens With New UV-blocker on Day and Night Driving Performance

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ClinicalTrials.gov Identifier: NCT03330275
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Visual Performance
Interventions Device: Investigational Contact Lens
Device: Commercial ACUVUE OASYS
Device: Commercial ACUVUE OASYS and Spectacles
Enrollment 24
Recruitment Details A total of 24 subjects were enrolled into this study. All enrolled subjects met all eligibility criteria and were dispensed a study lens. Of the dispensed subjects, all 24 completed the study.
Pre-assignment Details A 2X2 William's crossover design was utilized for visit 1. A 3X3 William's Crossover design was utilized for visits 2, 3 and 4.
Arm/Group Title Test/Control1 Control1/Test Test/Control2 Control2/Test Test/Control1/Control2 Test/Control2/Control1 Control1/Control2/Test Control1/Test/Control2 Control2/Control1/Test Control2/Test/Control1
Hide Arm/Group Description Subjects that were randomized to receive the Test lens during period 1 of visit 1 and the Control 1 lens during period 2 of visit 1. Subjects that were randomized to receive the Control 1 lens during period 1 of visit 1 and the Test lens during period 2 of visit 1. Subjects that were randomized to receive the Test lens during period 1 of visit 1 and the Control 2 lens during period 2 of visit 1. Subjects that were randomized to receive the Control 2 lens during period 1 of visit 1 and the Test lens during period 2 of visit 1. Subjects that were randomized to receive the Test lens during period 1, the Control 1 lens during period 2 and the Control 2 lens during period 3. This applies to visits 2, 3 and 4. Subjects that were randomized to receive the Test lens during period 1, the Control 2 lens during period 2 and the Control 1 lens during period 3. This applies to visits 2, 3 and 4. Subjects that were randomized to receive the Control 1 lens during period 1, the Control 2 lens during period 2 and the Test lens during period 3. This applies to visits 2, 3 and 4. Subjects that were randomized to receive the Control 1 lens during period 1, the Test lens during period 2 and the Control 2 lens during period 3. This applies to visits 2, 3 and 4. Subjects that were randomized to receive the Control 2 lens during period 1, the Control 1 lens during period 2 and the Test lens during period 3. This applies to visits 2, 3 and 4. Subjects that were randomized to receive the Control 2 lens during period 1, the Test lens during period 2 and the Control 1 lens during period 3. This applies to visits 2, 3 and 4.
Period Title: Visit 1 - Period 1
Started 6 6 6 6 0 0 0 0 0 0
Completed 6 6 6 6 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0
Period Title: Visit 1 - Period 2
Started 6 6 6 6 0 0 0 0 0 0
Completed 6 6 6 6 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0
Period Title: Visits 2, 3 and 4 - Period 1
Started 0 0 0 0 4 4 4 4 4 4
Completed 0 0 0 0 4 4 4 4 4 4
Not Completed 0 0 0 0 0 0 0 0 0 0
Period Title: Visits 2, 3 and 4 - Period 2
Started 0 0 0 0 4 4 4 4 4 4
Completed 0 0 0 0 4 4 4 4 4 4
Not Completed 0 0 0 0 0 0 0 0 0 0
Period Title: Visits 2, 3 and 4 - Period 3
Started 0 0 0 0 4 4 4 4 4 4
Completed 0 0 0 0 4 4 4 4 4 4
Not Completed 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Dispensed Subjects
Hide Arm/Group Description All subjects that were dispensed at least one study lens.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
29.8  (7.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
14
  58.3%
Male
10
  41.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Asian
9
  37.5%
White
13
  54.2%
Other
2
   8.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Australia Number Analyzed 24 participants
24
 100.0%
1.Primary Outcome
Title Overall Nighttime Driving Score
Hide Description 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 than the mean. Z scores follow a standard normal distribution (ranging from minus infinity to positive infinity). Overall Z score for night time driving was reported for each study lens.
Time Frame 15 Minutes Post Lens Fitting
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that completed the study without a major protocol violation.
Arm/Group Title Test Control 1 Control 2
Hide Arm/Group Description:
Subjects that wore the Test lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 1 lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 2 lens during any of the three study periods at either visit 3 or visit 4.
Overall Number of Participants Analyzed 24 24 24
Mean (Standard Deviation)
Unit of Measure: Z-Score
-0.308  (0.4718) -0.375  (0.4361) -0.430  (0.4761)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Control 1
Comments It was calculated that a total of 24 participants was required to show that the Test lens is non-inferior to the control 1 lens with 80% power. Sample size for this study was based on night driving only.
Type of Statistical Test Non-Inferiority
Comments A non-inferiority margin of -0.25 was used. Non-inferioirty was concluded if the lower limit of the 95% CI was above 0.25.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear Mixed Model
Comments Kenward and Roger Method was used for denominator degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.069
Confidence Interval (2-Sided) 95%
-0.045 to 0.183
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0574
Estimation Comments Mean difference was calculated as Test – Control 1
2.Secondary Outcome
Title Binocular Visual Acuity
Hide Description 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.
Time Frame 15 Minutes Post Lens Fitting
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that completed the study without a major protocol deviation.
Arm/Group Title Test Control 1 Control 2
Hide Arm/Group Description:
Subjects that wore the Test lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 1 lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 2 lens during any of the three study periods at either visit 3 or visit 4.
Overall Number of Participants Analyzed 24 24 24
Mean (Standard Deviation)
Unit of Measure: logMAR
0.251  (0.0722) 0.273  (0.0705) 0.298  (0.0739)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Control 1
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments A non-inferiority margin of 0.1 logMAR was used. Non-inferiority was concluded if the upper limit was below 0.1.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear Mixed Model
Comments Kenward and Roger Method was used for the degrees of freedom.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.028
Confidence Interval (2-Sided) 95%
-0.043 to -0.012
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0076
Estimation Comments Mean difference was calculated as Test – Control 1
3.Secondary Outcome
Title Binocular Contrast Threshold Without Glare
Hide Description 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.
Time Frame 15 Minutes Post Lens Fitting
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that completed the study without a major protocol deviation.
Arm/Group Title Test Control 1 Control 2
Hide Arm/Group Description:
Subjects that wore the Test lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 1 lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 2 lens during any of the three study periods at either visit 3 or visit 4.
Overall Number of Participants Analyzed 24 24 24
Measure Type: Number
Unit of Measure: Percentage of Participants
95% Contrast 100 100 100
80% Contrast 100 95.8 95.8
63% Contrast 91.7 91.7 87.5
50% 87.5 75.0 58.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Control 1
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence was concluded if 0 was contained in the 95% confidence interval.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.162
Confidence Interval (2-Sided) 95%
0.442 to 22.604
Estimation Comments Odds ratio was calculated as Test over Control 1
4.Secondary Outcome
Title Percentage of Road Signs Correctly Identified During Night Driving
Hide Description 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.
Time Frame 15 Minutes Post Lens Fitting
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that completed the study without a major protocol deviation.
Arm/Group Title Test Control 1 Control 2
Hide Arm/Group Description:
Subjects that wore the Test lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 1 lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 2 lens during any of the three study periods at either visit 3 or visit 4.
Overall Number of Participants Analyzed 24 24 24
Measure Type: Number
Unit of Measure: Percentage of participants
72.7 73.3 73.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Control 1
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence was concluded if 0 was contained in the 95% confidence interval.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.82 to 1.16
Estimation Comments Odds ratio was calculated as Test over Control1
5.Secondary Outcome
Title Average Distance to Correctly Identify Road Signs During Night Driving
Hide Description 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.
Time Frame 15 Minutes Post Lens Fitting
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that completed the study without a major protocol deviation.
Arm/Group Title Test Control 1 Control 2
Hide Arm/Group Description:
Subjects that wore the Test lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 1 lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 2 lens during any of the three study periods at either visit 3 or visit 4.
Overall Number of Participants Analyzed 24 24 24
Mean (Standard Deviation)
Unit of Measure: Meters
110.3  (23.45) 101.5  (25.53) 95.0  (22.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Control 1
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence was concluded if 0 was contained in the 95% confidence interval.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear Mixed Model
Comments Kenward and Roger Method was used for the denominator degrees of freedom.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 17.8
Confidence Interval (2-Sided) 95%
7.1 to 28.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.29
Estimation Comments Mean difference was calculated as Test – Control 1
6.Secondary Outcome
Title Percentage of Hazards Avoided During Night Driving
Hide Description 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.
Time Frame 15 Minutes Post Lens Fitting
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that completed the study without a major protocol deviation.
Arm/Group Title Test Control 1 Control 2
Hide Arm/Group Description:
Subjects that wore the Test lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 1 lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 2 lens during any of the three study periods at either visit 3 or visit 4.
Overall Number of Participants Analyzed 24 24 24
Measure Type: Number
Unit of Measure: Percentage of Participants
95.4 95.4 93.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Control 1
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence was concluded if 0 was contained in the 95% confidence interval.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.33 to 1.74
Estimation Comments Odds Ratio was calculated as Test over Control 1
7.Secondary Outcome
Title Average Pedestrian Recognition Distance
Hide Description 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 around the circuit to increase the instances of flashing lights and retro-reflective material being presented to the driver. The average distance to recognize a pedestrian for each lens type was reported.
Time Frame 15 Minutes Post Lens Fitting
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that completed the study without a major protocol deviation.
Arm/Group Title Test Control 1 Control 2
Hide Arm/Group Description:
Subjects that wore the Test lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 1 lens during any of the three study periods at either visit 3 or visit 4.
Subjects that wore the Control 2 lens during any of the three study periods at either visit 3 or visit 4.
Overall Number of Participants Analyzed 24 24 24
Mean (Standard Deviation)
Unit of Measure: Meters
208.3  (60.46) 201.1  (62.92) 195.5  (60.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Control 1
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence was concluded if 0 was contained in the 95% confidence interval.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear Mixed Model
Comments Kenward and Roger Method was used for denominator Degrees of Freedom.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
-11.4 to 20.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.93
Estimation Comments Mean difference was calculated as Test – Control 1
Time Frame Throughout the entire duration of the study. Approximately 2 weeks per subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control 1 Control 2 Test
Hide Arm/Group Description Subjects that wore the Control 1 lens at any point in the study. Subjects that wore the Control lens at any point in the study. Subjects that wore the Test lens at any point in the study.
All-Cause Mortality
Control 1 Control 2 Test
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control 1 Control 2 Test
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control 1 Control 2 Test
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: John Buch- SENIOR PRINCIPAL RESEARCH OPTOMETRIST
Organization: Johnson & Johnson Vision Care, Inc.
Phone: 904 443-1707
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03330275     History of Changes
Other Study ID Numbers: CR-5830
First Submitted: October 17, 2017
First Posted: November 6, 2017
Results First Submitted: May 7, 2018
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018