Trial Outcomes & Findings for Clinical Evaluation of Investigational Contact Lenses (NCT NCT02801396)
NCT ID: NCT02801396
Last Updated: 2017-07-11
Results Overview
CLUE Handling is assessed using the Contact Lens User Experience (CLUE™) Questionnaire. CLUE™ is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable / positive response. 97% of the scores fall within 0 and 120 (mean +/- 3XSD).
COMPLETED
NA
116 participants
30 Minutes Post Insertion
2017-07-11
Participant Flow
A total of 116 subjects were enrolled into the study. Of the enrolled subjects 15 were not dispensed a study lens. A total of 101 subjects were dispensed a study lens. Of the dispensed subjects 1 was discontinued and 100 subjects completed the study.
Participant milestones
| Measure |
Test1/Test2/Control
Subjects that received Test lens 1 during the first period, Test lens 2 during the second period and the Control lens during the third period.
|
Test1/Control/Test2
Subjects that received Test lens 1 during the first period, the Control lens during the second period and Test lens 2 during the third period.
|
Test2/Test1/Control
Subjects that received Test lens 2 during the first period, Test lens 1 during the second period and the Control lens during the third period.
|
Test2/Control/Test1
Subjects that received Test lens 2 during the first period, the Control lens during the second and the Test 1 lens during the third period.
|
Control/Test1/Test2
Subjects that received the Control lens during the first period, Test lens 1 during the second period and Test lens 2 during the third period.
|
Control/Test2/Test1
Subjects that received the Control lens during the first period, Test 2 lens during the second period and Test lens 1 during the third period.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
17
|
17
|
17
|
16
|
17
|
17
|
|
Period 1
COMPLETED
|
17
|
17
|
17
|
16
|
16
|
17
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2
STARTED
|
17
|
17
|
17
|
16
|
16
|
17
|
|
Period 2
COMPLETED
|
17
|
17
|
17
|
16
|
16
|
17
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
17
|
17
|
17
|
16
|
16
|
17
|
|
Period 3
COMPLETED
|
17
|
17
|
17
|
16
|
16
|
17
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test1/Test2/Control
Subjects that received Test lens 1 during the first period, Test lens 2 during the second period and the Control lens during the third period.
|
Test1/Control/Test2
Subjects that received Test lens 1 during the first period, the Control lens during the second period and Test lens 2 during the third period.
|
Test2/Test1/Control
Subjects that received Test lens 2 during the first period, Test lens 1 during the second period and the Control lens during the third period.
|
Test2/Control/Test1
Subjects that received Test lens 2 during the first period, the Control lens during the second and the Test 1 lens during the third period.
|
Control/Test1/Test2
Subjects that received the Control lens during the first period, Test lens 1 during the second period and Test lens 2 during the third period.
|
Control/Test2/Test1
Subjects that received the Control lens during the first period, Test 2 lens during the second period and Test lens 1 during the third period.
|
|---|---|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Clinical Evaluation of Investigational Contact Lenses
Baseline characteristics by cohort
| Measure |
Dispensed Subjects
n=101 Participants
All subjects that were dispensed at least one study lens.
|
|---|---|
|
Age, Continuous
|
32.43 Years
STANDARD_DEVIATION 9.768 • n=99 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
101 Participants
n=99 Participants
|
|
Region of Enrollment
China
|
101 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 Minutes Post InsertionPopulation: Subjects that completed all study visits without a major protocol deviation.
CLUE Handling is assessed using the Contact Lens User Experience (CLUE™) Questionnaire. CLUE™ is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable / positive response. 97% of the scores fall within 0 and 120 (mean +/- 3XSD).
Outcome measures
| Measure |
Test1
n=99 Participants
Subjects that wore the Test 1 lens during any of the 3 study periods.
|
Test 2
n=99 Participants
Subjects that wore the Test 2 lens during any of the 3 study periods.
|
Control
n=99 Participants
Subjects that wore the control lens during any of the 3 study periods.
|
|---|---|---|---|
|
CLUE Handling
|
55.73 Units on a scale
Standard Deviation 20.146
|
57.58 Units on a scale
Standard Deviation 20.109
|
64.39 Units on a scale
Standard Deviation 19.825
|
PRIMARY outcome
Timeframe: 30 Minutes Post InsertionPopulation: Subjects that completed all study visits without a major protocol deviation.
Distance time controlled Visual Performance (LogMAR) was assessed for each subject eye under bright-illumination high-contrast lighting conditions at 4m using an ETDRS chart. The average visual performance (LogMAR) was reported for each study lens.
Outcome measures
| Measure |
Test1
n=198 Eyes
Subjects that wore the Test 1 lens during any of the 3 study periods.
|
Test 2
n=198 Eyes
Subjects that wore the Test 2 lens during any of the 3 study periods.
|
Control
n=198 Eyes
Subjects that wore the control lens during any of the 3 study periods.
|
|---|---|---|---|
|
Visual Performance (LogMar)
|
0.00 LogMAR
Standard Deviation 0.082
|
0.00 LogMAR
Standard Deviation 0.082
|
0.01 LogMAR
Standard Deviation 0.082
|
PRIMARY outcome
Timeframe: 30 Minutes Post InsertionPopulation: Subjects that completed all study visits without a major protocol deviation.
Mechanical lens fit will be assessed for each subject and eye using a slit lamp. Lens fit is a binary response and 'Yes' = Acceptable Fit and 'No' = Unacceptable Fit. Lens fit is assessed using Lens centration, limbal exposure, primary gaze movement, up-gaze movement, edge lift, lens tightness. Unacceptable fit will be declared if there is any of the following present: limbal exposure, edge lift, excessive movement in primary or up-gaze or insufficient movement in primary gaze and up-gaze. The Percentage of subject eyes with acceptable lens fit will be reported.
Outcome measures
| Measure |
Test1
n=198 Eyes
Subjects that wore the Test 1 lens during any of the 3 study periods.
|
Test 2
n=198 Eyes
Subjects that wore the Test 2 lens during any of the 3 study periods.
|
Control
n=198 Eyes
Subjects that wore the control lens during any of the 3 study periods.
|
|---|---|---|---|
|
Percentage of Eyes With Acceptable Mechanical Lens Fit
|
95 Percentage of eyes
|
97 Percentage of eyes
|
91 Percentage of eyes
|
PRIMARY outcome
Timeframe: 30 Minutes Post InsertionPopulation: Subjects that completed all study visits without a major protocol deviation.
Cosmetic lens fitting is assessed for each subject eye in the primary gaze position without a slit lamp. Cosmetic lens fit is a binary response and is reported as acceptable or unacceptable. The Percentage of subject eyes with acceptable cosmetic lens fitting is reported.
Outcome measures
| Measure |
Test1
n=198 Eyes
Subjects that wore the Test 1 lens during any of the 3 study periods.
|
Test 2
n=198 Eyes
Subjects that wore the Test 2 lens during any of the 3 study periods.
|
Control
n=198 Eyes
Subjects that wore the control lens during any of the 3 study periods.
|
|---|---|---|---|
|
Percentage of Eyes With Acceptable Cosmetic Lens Fit
|
99.5 Percentage of eyes
|
99.5 Percentage of eyes
|
99.5 Percentage of eyes
|
Adverse Events
Test1
Test2
Control
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
Restriction type: GT60