Trial Outcomes & Findings for Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3 (NCT NCT02950545)
NCT ID: NCT02950545
Last Updated: 2021-10-06
Results Overview
This scale measures driving performance in the simulator. It is the sum of the z scores from 15 different driving simulator variables related to braking, steering, speed control and judgment. The scale has no fixed limits. A score of 0 indicates average performance. Higher scores indicate better performance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
1 day
Results posted on
2021-10-06
Participant Flow
Participant milestones
| Measure |
Crossover Order 1
Placebo, Spherical, then Toric lenses
|
Crossover Order 2
Placebo, Toric, then Spherical lenses
|
Crossover Order 3
Spherical, Placebo, then Toric lenses
|
Crossover Order 4
Spherical, Toric, then Placebo lenses
|
Crossover Order 5
Toric, Placebo, then Spherical lenses
|
Crossover Order 6
Toric, Spherical, then Placebo lenses
|
|---|---|---|---|---|---|---|
|
Session 1 (70 Minutes)
STARTED
|
9
|
9
|
7
|
8
|
8
|
10
|
|
Session 1 (70 Minutes)
COMPLETED
|
9
|
9
|
7
|
8
|
8
|
9
|
|
Session 1 (70 Minutes)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout 1 (5 Minutes)
STARTED
|
9
|
9
|
7
|
8
|
8
|
9
|
|
Washout 1 (5 Minutes)
COMPLETED
|
8
|
9
|
7
|
7
|
8
|
8
|
|
Washout 1 (5 Minutes)
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
1
|
|
Session 2 (70 Minutes)
STARTED
|
8
|
9
|
7
|
7
|
8
|
8
|
|
Session 2 (70 Minutes)
COMPLETED
|
8
|
9
|
7
|
7
|
7
|
8
|
|
Session 2 (70 Minutes)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Washout 2 (5 Minutes)
STARTED
|
8
|
9
|
7
|
7
|
7
|
8
|
|
Washout 2 (5 Minutes)
COMPLETED
|
7
|
9
|
7
|
7
|
7
|
8
|
|
Washout 2 (5 Minutes)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Session 3 (70 Minutes)
STARTED
|
7
|
9
|
7
|
7
|
7
|
8
|
|
Session 3 (70 Minutes)
COMPLETED
|
7
|
9
|
7
|
7
|
7
|
7
|
|
Session 3 (70 Minutes)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Crossover Order 1
Placebo, Spherical, then Toric lenses
|
Crossover Order 2
Placebo, Toric, then Spherical lenses
|
Crossover Order 3
Spherical, Placebo, then Toric lenses
|
Crossover Order 4
Spherical, Toric, then Placebo lenses
|
Crossover Order 5
Toric, Placebo, then Spherical lenses
|
Crossover Order 6
Toric, Spherical, then Placebo lenses
|
|---|---|---|---|---|---|---|
|
Session 1 (70 Minutes)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout 1 (5 Minutes)
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
1
|
|
Session 2 (70 Minutes)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Washout 2 (5 Minutes)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Session 3 (70 Minutes)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Crossover Order 1
n=9 Participants
Placebo, Spherical, Then Toric Lenses
|
Crossover Order 2
n=9 Participants
Placebo, Toric, Then Spherical Lenses
|
Crossover Order 3
n=7 Participants
Spherical, Placebo, Then Toric Lenses
|
Crossover Order 4
n=8 Participants
Spherical, Toric, Then Placebo Lenses
|
Crossover Order 5
n=8 Participants
Toric, Placebo, Then Spherical Lenses
|
Crossover Order 6
n=10 Participants
Toric, Spherical, Then Placebo Lenses
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=51 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=10 Participants
|
51 Participants
n=51 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=51 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=10 Participants
|
36 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
15 Participants
n=51 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
7 participants
n=7 Participants
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
10 participants
n=10 Participants
|
51 participants
n=51 Participants
|
|
Tactical composite
Placebo Lenses
|
-8.93 sum of z scores
STANDARD_DEVIATION 6.42 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-4.94 sum of z scores
STANDARD_DEVIATION 3.00 • n=8 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
5.32 sum of z scores
STANDARD_DEVIATION 1.77 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
3.32 sum of z scores
STANDARD_DEVIATION 3.49 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-0.58 sum of z scores
STANDARD_DEVIATION 5.77 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
2.80 sum of z scores
STANDARD_DEVIATION 2.82 • n=6 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-0.69 sum of z scores
STANDARD_DEVIATION 6.44 • n=42 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
|
Tactical composite
Spherical Lenses
|
0.99 sum of z scores
STANDARD_DEVIATION 6.27 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
2.26 sum of z scores
STANDARD_DEVIATION 5.66 • n=8 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-2.59 sum of z scores
STANDARD_DEVIATION 3.24 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-4.67 sum of z scores
STANDARD_DEVIATION 4.73 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
3.53 sum of z scores
STANDARD_DEVIATION 3.39 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
2.78 sum of z scores
STANDARD_DEVIATION 1.81 • n=6 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
0.37 sum of z scores
STANDARD_DEVIATION 5.22 • n=42 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
|
Tactical composite
Toric Lenses
|
1.92 sum of z scores
STANDARD_DEVIATION 5.00 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
1.88 sum of z scores
STANDARD_DEVIATION 3.51 • n=8 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
5.32 sum of z scores
STANDARD_DEVIATION 3.16 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
3.71 sum of z scores
STANDARD_DEVIATION 2.66 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-5.18 sum of z scores
STANDARD_DEVIATION 4.55 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-7.03 sum of z scores
STANDARD_DEVIATION 6.06 • n=6 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
0.32 sum of z scores
STANDARD_DEVIATION 6.00 • n=42 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
|
Operational composite
Placebo lenses
|
-3.95 sum of z scores
STANDARD_DEVIATION 3.95 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-4.91 sum of z scores
STANDARD_DEVIATION 4.15 • n=8 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-2.85 sum of z scores
STANDARD_DEVIATION 3.23 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-0.78 sum of z scores
STANDARD_DEVIATION 4.51 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-7.43 sum of z scores
STANDARD_DEVIATION 4.36 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-4.40 sum of z scores
STANDARD_DEVIATION 6.28 • n=6 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
-4.06 sum of z scores
STANDARD_DEVIATION 4.64 • n=42 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
|
Operational composite
Spherical lenses
|
1.28 sum of z scores
STANDARD_DEVIATION 1.32 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
1.76 sum of z scores
STANDARD_DEVIATION 1.27 • n=8 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
1.61 sum of z scores
STANDARD_DEVIATION 0.60 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
3.15 sum of z scores
STANDARD_DEVIATION 1.12 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
2.70 sum of z scores
STANDARD_DEVIATION 0.74 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
1.52 sum of z scores
STANDARD_DEVIATION 1.39 • n=6 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
2.01 sum of z scores
STANDARD_DEVIATION 1.25 • n=42 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
|
Operational composite
Toric lenses
|
2.29 sum of z scores
STANDARD_DEVIATION 1.16 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
1.70 sum of z scores
STANDARD_DEVIATION 1.08 • n=8 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
3.01 sum of z scores
STANDARD_DEVIATION 2.01 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
2.45 sum of z scores
STANDARD_DEVIATION 1.53 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
1.30 sum of z scores
STANDARD_DEVIATION 0.44 • n=7 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
1.56 sum of z scores
STANDARD_DEVIATION 1.99 • n=6 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
2.05 sum of z scores
STANDARD_DEVIATION 1.48 • n=42 Participants • Only subjects who completed all 3 lens conditions were analyzed. Nine were not analyzed due to study withdrawal (7), receiving the wrong contact lens prescription (1), and having missing data.(1).
|
PRIMARY outcome
Timeframe: 1 dayPopulation: All participants who completed the 3 simulated driving sessions and who had complete and accurate data records were included in the analysis.
This scale measures driving performance in the simulator. It is the sum of the z scores from 15 different driving simulator variables related to braking, steering, speed control and judgment. The scale has no fixed limits. A score of 0 indicates average performance. Higher scores indicate better performance.
Outcome measures
| Measure |
All Study Participants
n=42 Participants
Each participant completed (1) Simulated driving with Placebo Lenses (AcuVue Oasys Bandage Lenses with no prescription), (2) Simulated driving with Spherical Lenses (1-DAY ACUVUE® MOIST contact lenses), (3) Simulated driving with Toric Lenses (1-DAY ACUVUE® MOIST for ASTIGMATISM contact...
|
|---|---|
|
Tactical Composite Score
Placebo
|
0.34 score on a scale
Standard Deviation 2.44
|
|
Tactical Composite Score
Sphere
|
-0.01 score on a scale
Standard Deviation 2.65
|
|
Tactical Composite Score
Toric
|
-0.33 score on a scale
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All participants who completed the 3 simulated driving sessions and who had complete and accurate data records were included in the analysis.
This scale measures driving-relevant visual performance. It is the sum of the z scores from 5 different driving simulator variables related to visual testing done in the simulator. The scale has no fixed limits. A score of 0 indicates average performance. Higher scores indicate better performance.
Outcome measures
| Measure |
All Study Participants
n=42 Participants
Each participant completed (1) Simulated driving with Placebo Lenses (AcuVue Oasys Bandage Lenses with no prescription), (2) Simulated driving with Spherical Lenses (1-DAY ACUVUE® MOIST contact lenses), (3) Simulated driving with Toric Lenses (1-DAY ACUVUE® MOIST for ASTIGMATISM contact...
|
|---|---|
|
Operational Composite Score
Placebo
|
-4.06 score on a scale
Standard Deviation 4.64
|
|
Operational Composite Score
Sphere
|
2.01 score on a scale
Standard Deviation 1.25
|
|
Operational Composite Score
Toric
|
2.05 score on a scale
Standard Deviation 1.48
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Spherical
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Toric
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Participants wore the placebo contact lenses during testing
|
Spherical
n=51 participants at risk
Participants wore the spherical contact lenses during testing
|
Toric
n=51 participants at risk
Participants wore the toric contact lenses during testing
|
|---|---|---|---|
|
General disorders
Simulation sickness
|
3.9%
2/51 • 10 months
|
3.9%
2/51 • 10 months
|
5.9%
3/51 • 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place