Trial Outcomes & Findings for An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort (NCT NCT03733899)
NCT ID: NCT03733899
Last Updated: 2025-04-25
Results Overview
Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
5 and 10 Minutes post-treament
Results posted on
2025-04-25
Participant Flow
A total of 22 subjects were enrolled in this study. Of those enrolled, 20 were dispensed at least one study lens while 2 subjects failed to meet all eligibility criteria. Of those dispensed, 17 completed the study while 3 subjects were discontinued.
Participant milestones
| Measure |
Lower Lid Margin/Upper Lid Margin/Cornea
Subjects assigned to recieved two treatmens contralaterally, in the lower lid margin during period 1, the upper lid margin during period 2 and the cornea at period 3.
|
Lower Lid Margin/Cornea/Upper Lid Margin
Subjects assigned to recieved two treatmens contralaterally, in the lower lid margin during period 1, the cornea during period 2 and the upper lid margin during period 3.
|
Upper Lid Margin/Lower Lid Margin/Cornea
Subjects assigned to recieved two treatmens contralaterally, in the upper lid margin during period 1, the lower lid margin during period 2 and the cornea during period 3.
|
Upper Lid Margin/Cornea/Lower Lid Margin
Subjects assigned to recieved two treatmens contralaterally, in the upper lid margin during period 1, the cornea during period 2 and the lower lid margin during period 3.
|
Cornea/Lower Lid Margin/Upper Lid Margin
Subjects assigned to recieved two treatmens contralaterally, in the Cornea during period 1, the lower lid margin during period 2 and the upper lid maring during period 3.
|
Cornea/Upper Lid Margin/Lower Lid Margin
Subjects assigned to recieved two treatmens contralaterally, in the Cornea during period 1, the upper lid margin during period 2 and the lower lid maring during period 3.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
3
|
3
|
3
|
4
|
4
|
3
|
|
Period 1
COMPLETED
|
3
|
3
|
3
|
4
|
4
|
2
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 2
STARTED
|
3
|
3
|
3
|
4
|
4
|
2
|
|
Period 2
COMPLETED
|
3
|
2
|
3
|
4
|
4
|
2
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
3
|
2
|
3
|
4
|
4
|
2
|
|
Period 3
COMPLETED
|
2
|
2
|
3
|
4
|
4
|
2
|
|
Period 3
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lower Lid Margin/Upper Lid Margin/Cornea
Subjects assigned to recieved two treatmens contralaterally, in the lower lid margin during period 1, the upper lid margin during period 2 and the cornea at period 3.
|
Lower Lid Margin/Cornea/Upper Lid Margin
Subjects assigned to recieved two treatmens contralaterally, in the lower lid margin during period 1, the cornea during period 2 and the upper lid margin during period 3.
|
Upper Lid Margin/Lower Lid Margin/Cornea
Subjects assigned to recieved two treatmens contralaterally, in the upper lid margin during period 1, the lower lid margin during period 2 and the cornea during period 3.
|
Upper Lid Margin/Cornea/Lower Lid Margin
Subjects assigned to recieved two treatmens contralaterally, in the upper lid margin during period 1, the cornea during period 2 and the lower lid margin during period 3.
|
Cornea/Lower Lid Margin/Upper Lid Margin
Subjects assigned to recieved two treatmens contralaterally, in the Cornea during period 1, the lower lid margin during period 2 and the upper lid maring during period 3.
|
Cornea/Upper Lid Margin/Lower Lid Margin
Subjects assigned to recieved two treatmens contralaterally, in the Cornea during period 1, the upper lid margin during period 2 and the lower lid maring during period 3.
|
|---|---|---|---|---|---|---|
|
Period 1
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 2
Unscuccessful Treatment
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 3
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort
Baseline characteristics by cohort
| Measure |
All Dispensed Subjects
n=20 Participants
All subjects dispensed at least one study lens.
|
|---|---|
|
Age, Continuous
|
26.2 Years
STANDARD_DEVIATION 70.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African Amercian
|
2 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Count of Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 and 10 Minutes post-treamentPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawl from the study or deviation from protocol.
Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Outcome measures
| Measure |
Test (Anesthetic)- Cornea
n=12 eyes
Eyes that instilled the Test (Anesthetic) in either the right or left corneal ocular region.
|
Placebo- Cornea
n=15 eyes
Eyes that instilled the Placebo in either the right or left corneal ocular region.
|
Test (Anesthetic) - Upper Lid Margin
n=18 eyes
Eyes that instilled the Test in either the right or left upper lid margin.
|
Placebo- Upper Lid Margin
n=17 eyes
Eyes that instilled the Placebo in either the right or left upper lid margin.
|
Test (Anesthetic)- Lower Lid Margin
n=19 eyes
Eyes that instilled the Test in either the right or left lower lid margin.
|
Placebo- Lower Lid Margin
n=18 eyes
Eyes that instilled the Placebo in either the right or left lower lid margin.
|
|---|---|---|---|---|---|---|
|
Subjective Comfort Scores
5- Mintues Post Treatment
|
79.25 Units on a Scale
Standard Deviation 8.925
|
70.93 Units on a Scale
Standard Deviation 20.838
|
61.00 Units on a Scale
Standard Deviation 20.807
|
61.94 Units on a Scale
Standard Deviation 16.783
|
64.00 Units on a Scale
Standard Deviation 20.915
|
61.06 Units on a Scale
Standard Deviation 21.292
|
|
Subjective Comfort Scores
10- Mintues Post Treatment
|
18.50 Units on a Scale
Standard Deviation 10.265
|
72.33 Units on a Scale
Standard Deviation 20.430
|
65.11 Units on a Scale
Standard Deviation 21.766
|
64.00 Units on a Scale
Standard Deviation 19.239
|
70.79 Units on a Scale
Standard Deviation 16.511
|
63.17 Units on a Scale
Standard Deviation 20.667
|
PRIMARY outcome
Timeframe: 14-Hours upon Lens-Insertion (pre-treatment), and 10 Minutes post-treamentPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawl from the study or deviation from protocol.
Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable. Subjects wore their habitual contacts during the pre-treatment assessment.
Outcome measures
| Measure |
Test (Anesthetic)- Cornea
n=12 eyes
Eyes that instilled the Test (Anesthetic) in either the right or left corneal ocular region.
|
Placebo- Cornea
n=15 eyes
Eyes that instilled the Placebo in either the right or left corneal ocular region.
|
Test (Anesthetic) - Upper Lid Margin
n=18 eyes
Eyes that instilled the Test in either the right or left upper lid margin.
|
Placebo- Upper Lid Margin
n=17 eyes
Eyes that instilled the Placebo in either the right or left upper lid margin.
|
Test (Anesthetic)- Lower Lid Margin
n=19 eyes
Eyes that instilled the Test in either the right or left lower lid margin.
|
Placebo- Lower Lid Margin
n=18 eyes
Eyes that instilled the Placebo in either the right or left lower lid margin.
|
|---|---|---|---|---|---|---|
|
Change in Subjective Comfort Scores From Pre-treatment to Post-treatment
5- Mintues Post Treatment
|
79.25 Units on a Scale
Standard Deviation 8.925
|
70.93 Units on a Scale
Standard Deviation 20.838
|
61.00 Units on a Scale
Standard Deviation 20.807
|
61.94 Units on a Scale
Standard Deviation 16.783
|
64.00 Units on a Scale
Standard Deviation 20.915
|
61.06 Units on a Scale
Standard Deviation 21.292
|
|
Change in Subjective Comfort Scores From Pre-treatment to Post-treatment
10- Mintues Post Treatment
|
18.50 Units on a Scale
Standard Deviation 10.265
|
72.33 Units on a Scale
Standard Deviation 20.430
|
65.11 Units on a Scale
Standard Deviation 21.766
|
64.00 Units on a Scale
Standard Deviation 19.239
|
70.79 Units on a Scale
Standard Deviation 16.511
|
63.17 Units on a Scale
Standard Deviation 20.667
|
|
Change in Subjective Comfort Scores From Pre-treatment to Post-treatment
Pre-treatment
|
62.35 Units on a Scale
Standard Deviation 23.238
|
60.16 Units on a Scale
Standard Deviation 24.862
|
56.67 Units on a Scale
Standard Deviation 24.867
|
58.35 Units on a Scale
Standard Deviation 24.746
|
60.11 Units on a Scale
Standard Deviation 24.669
|
57.94 Units on a Scale
Standard Deviation 21.939
|
PRIMARY outcome
Timeframe: Immediately after lens-insertion, 5 and 10 minutes post-treatmentPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Outcome measures
| Measure |
Test (Anesthetic)- Cornea
n=12 eyes
Eyes that instilled the Test (Anesthetic) in either the right or left corneal ocular region.
|
Placebo- Cornea
n=18 eyes
Eyes that instilled the Placebo in either the right or left corneal ocular region.
|
Test (Anesthetic) - Upper Lid Margin
n=19 eyes
Eyes that instilled the Test in either the right or left upper lid margin.
|
Placebo- Upper Lid Margin
Eyes that instilled the Placebo in either the right or left upper lid margin.
|
Test (Anesthetic)- Lower Lid Margin
Eyes that instilled the Test in either the right or left lower lid margin.
|
Placebo- Lower Lid Margin
Eyes that instilled the Placebo in either the right or left lower lid margin.
|
|---|---|---|---|---|---|---|
|
Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic
Immediate Post Lens Insertion
|
78.06 Units on a Scale
Standard Deviation 17.243
|
73.33 Units on a Scale
Standard Deviation 22.646
|
80.37 Units on a Scale
Standard Deviation 14.064
|
—
|
—
|
—
|
|
Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic
5-Minutes Post Treatment
|
79.25 Units on a Scale
Standard Deviation 8.925
|
61.00 Units on a Scale
Standard Deviation 20.807
|
64.00 Units on a Scale
Standard Deviation 20.915
|
—
|
—
|
—
|
|
Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic
10 Minutes Post Treatment
|
78.50 Units on a Scale
Standard Deviation 10.265
|
65.11 Units on a Scale
Standard Deviation 21.766
|
70.79 Units on a Scale
Standard Deviation 16.511
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 and 10 minutes post treatmentPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Outcome measures
| Measure |
Test (Anesthetic)- Cornea
n=12 eyes
Eyes that instilled the Test (Anesthetic) in either the right or left corneal ocular region.
|
Placebo- Cornea
n=18 eyes
Eyes that instilled the Placebo in either the right or left corneal ocular region.
|
Test (Anesthetic) - Upper Lid Margin
n=19 eyes
Eyes that instilled the Test in either the right or left upper lid margin.
|
Placebo- Upper Lid Margin
Eyes that instilled the Placebo in either the right or left upper lid margin.
|
Test (Anesthetic)- Lower Lid Margin
Eyes that instilled the Test in either the right or left lower lid margin.
|
Placebo- Lower Lid Margin
Eyes that instilled the Placebo in either the right or left lower lid margin.
|
|---|---|---|---|---|---|---|
|
Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic
5-Minutes Post Treatment
|
79.25 Units on a Scale
Standard Deviation 8.925
|
61.00 Units on a Scale
Standard Deviation 20.807
|
64.00 Units on a Scale
Standard Deviation 20.915
|
—
|
—
|
—
|
|
Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic
10 Minutes Post Treatment
|
78.50 Units on a Scale
Standard Deviation 10.265
|
65.11 Units on a Scale
Standard Deviation 21.766
|
70.79 Units on a Scale
Standard Deviation 16.511
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 hours upon lens-insertion (pre-treatment), 5- and 10- minutes post-treatmentPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Outcome measures
| Measure |
Test (Anesthetic)- Cornea
n=12 eyes
Eyes that instilled the Test (Anesthetic) in either the right or left corneal ocular region.
|
Placebo- Cornea
n=18 eyes
Eyes that instilled the Placebo in either the right or left corneal ocular region.
|
Test (Anesthetic) - Upper Lid Margin
n=19 eyes
Eyes that instilled the Test in either the right or left upper lid margin.
|
Placebo- Upper Lid Margin
Eyes that instilled the Placebo in either the right or left upper lid margin.
|
Test (Anesthetic)- Lower Lid Margin
Eyes that instilled the Test in either the right or left lower lid margin.
|
Placebo- Lower Lid Margin
Eyes that instilled the Placebo in either the right or left lower lid margin.
|
|---|---|---|---|---|---|---|
|
Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions
Pre-Treatment
|
62.35 Units on a Scale
Standard Deviation 23.238
|
56.67 Units on a Scale
Standard Deviation 24.867
|
60.16 Units on a Scale
Standard Deviation 24.862
|
—
|
—
|
—
|
|
Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions
5-Minutes Post Treatment
|
79.25 Units on a Scale
Standard Deviation 8.925
|
61.00 Units on a Scale
Standard Deviation 20.807
|
64.00 Units on a Scale
Standard Deviation 20.915
|
—
|
—
|
—
|
|
Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions
10-Minutes Post Treatment
|
78.50 Units on a Scale
Standard Deviation 10.265
|
65.11 Units on a Scale
Standard Deviation 21.766
|
70.79 Units on a Scale
Standard Deviation 16.511
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately before lens-insertion (pre-insertion), 30 seconds after lens removalPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawl from study or deviation from protocol.
Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Outcome measures
| Measure |
Test (Anesthetic)- Cornea
n=12 Eyes
Eyes that instilled the Test (Anesthetic) in either the right or left corneal ocular region.
|
Placebo- Cornea
Eyes that instilled the Placebo in either the right or left corneal ocular region.
|
Test (Anesthetic) - Upper Lid Margin
Eyes that instilled the Test in either the right or left upper lid margin.
|
Placebo- Upper Lid Margin
Eyes that instilled the Placebo in either the right or left upper lid margin.
|
Test (Anesthetic)- Lower Lid Margin
Eyes that instilled the Test in either the right or left lower lid margin.
|
Placebo- Lower Lid Margin
Eyes that instilled the Placebo in either the right or left lower lid margin.
|
|---|---|---|---|---|---|---|
|
Subjective Comfort Difference Between Post-removal and Preinsertion Within Anesthetic and Cornea
Pre-Insertion
|
81.53 Units on a Scale
Standard Deviation 17.784
|
—
|
—
|
—
|
—
|
—
|
|
Subjective Comfort Difference Between Post-removal and Preinsertion Within Anesthetic and Cornea
Post-Removal
|
69.12 Units on a Scale
Standard Deviation 21.508
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test (Anesthetic)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas Karkkainen, OD, MS, FAAO Sr. Principal Research Optometrist
Johnson & Johnson Vision Care, Inc.
Phone: 904-443-3402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60