Trial Outcomes & Findings for A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens (NCT NCT03499067)
NCT ID: NCT03499067
Last Updated: 2020-08-26
Results Overview
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
COMPLETED
58 participants
Baseline
2020-08-26
Participant Flow
Participant milestones
| Measure |
Test Lens Then Control Lens
Subjects were randomized to wear test lens for one month then control lens for one month during the cross-over study.
Test lens: Contact lens
Control lens: Contact lens
|
Control Lens Then Test Lens
Subjects were randomized to wear control lens for one month then test lens for one month during the cross-over study.
Test lens: Contact lens
Control lens: Contact lens
|
|---|---|---|
|
First Intervention
STARTED
|
27
|
31
|
|
First Intervention
COMPLETED
|
22
|
24
|
|
First Intervention
NOT COMPLETED
|
5
|
7
|
|
Second Intervention
STARTED
|
22
|
24
|
|
Second Intervention
COMPLETED
|
22
|
24
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test Lens Then Control Lens
Subjects were randomized to wear test lens for one month then control lens for one month during the cross-over study.
Test lens: Contact lens
Control lens: Contact lens
|
Control Lens Then Test Lens
Subjects were randomized to wear control lens for one month then test lens for one month during the cross-over study.
Test lens: Contact lens
Control lens: Contact lens
|
|---|---|---|
|
First Intervention
Physician Decision
|
2
|
1
|
|
First Intervention
Withdrawal by Subject
|
3
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study
n=58 Participants
Total participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=58 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=58 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=58 Participants
|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 6 • n=58 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=58 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=58 Participants
|
PRIMARY outcome
Timeframe: BaselineLens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Lens Surface Wettability
|
3.26 units on a scale
Standard Deviation 0.48
|
3.26 units on a scale
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: 2-weeksLens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Lens Surface Wettability
|
3.18 units on a scale
Standard Deviation 0.53
|
3.25 units on a scale
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: 4-weeksLens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Lens Surface Wettability
|
3.11 units on a scale
Standard Deviation 0.51
|
3.01 units on a scale
Standard Deviation 0.62
|
PRIMARY outcome
Timeframe: BaselineLens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits, 1: 5 or less small deposits (\<0.1mm), 2: \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Lens Surface Deposits
|
0.02 units on a scale
Standard Deviation 0.12
|
0.04 units on a scale
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: 2-weeksLens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (\<0.1mm), 2: \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface).
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Lens Surface Deposits
|
0.30 units on a scale
Standard Deviation 0.60
|
0.26 units on a scale
Standard Deviation 0.53
|
PRIMARY outcome
Timeframe: 4-weeksLens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (\<0.1mm), 2: \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Lens Surface Deposits
|
0.35 units on a scale
Standard Deviation 0.54
|
0.38 units on a scale
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: BaselineOverall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Overall Lens Fit Acceptance
|
3.30 units on a scale
Standard Deviation 0.33
|
3.27 units on a scale
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: 2-WeeksOverall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Overall Lens Fit Acceptance
|
3.28 units on a scale
Standard Deviation 0.41
|
3.31 units on a scale
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: 4-WeeksOverall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Overall Lens Fit Acceptance
|
3.31 units on a scale
Standard Deviation 0.36
|
3.13 units on a scale
Standard Deviation 0.53
|
PRIMARY outcome
Timeframe: BaselineLens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Optimal
|
49 percentage of participants
|
38 percentage of participants
|
|
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Slightly Decentered
|
45 percentage of participants
|
55 percentage of participants
|
|
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Extremely Decentered
|
6 percentage of participants
|
7 percentage of participants
|
PRIMARY outcome
Timeframe: 2-weeksLens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Optimal
|
57 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Slightly Decentered
|
43 percentage of participants
|
52 percentage of participants
|
|
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Extremely Decentered
|
0 percentage of participants
|
8 percentage of participants
|
PRIMARY outcome
Timeframe: 4-weeksLens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Optimal
|
59 percentage of participants
|
33 percentage of participants
|
|
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Slightly Decentered
|
40 percentage of participants
|
59 percentage of participants
|
|
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Extremely Decentered
|
1 percentage of participants
|
8 percentage of participants
|
SECONDARY outcome
Timeframe: BaselineBulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Bulbar Conjunctiva Hyperaemia
|
1.11 units on a scale
Standard Deviation 0.49
|
1.11 units on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: 2-weeksBulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Bulbar Conjunctiva Hyperaemia
|
1.20 units on a scale
Standard Deviation 0.45
|
1.23 units on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 4-weeksBulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Bulbar Conjunctiva Hyperaemia
|
1.15 units on a scale
Standard Deviation 0.47
|
1.27 units on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: BaselineLimbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Limbal Conjunctiva Hyperaemia
|
0.57 units on a scale
Standard Deviation 0.35
|
0.57 units on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 2-weeksLimbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Limbal Conjunctiva Hyperaemia
|
0.71 units on a scale
Standard Deviation 0.40
|
0.63 units on a scale
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: 4-weeksLimbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Outcome measures
| Measure |
Test Lens
n=46 Participants
Subjects were randomized to wear test contact lens for one month in this cross-over study.
Test lens: Contact lens
|
Control Lens
n=46 Participants
Subjects were randomized to wear control contact lens for one month in this cross-over study.
Control lens: Contact lens
|
|---|---|---|
|
Limbal Conjunctiva Hyperaemia
|
0.65 units on a scale
Standard Deviation 0.42
|
0.76 units on a scale
Standard Deviation 0.35
|
Adverse Events
Test Lens
Control Lens
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place