Trial Outcomes & Findings for Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients (NCT NCT03995355)
NCT ID: NCT03995355
Last Updated: 2023-07-03
Results Overview
Subjective overall ocular comfort was assessed at baseline, and at the 30-Day follow-up using a Visual Analogue Scale (VAS) ranging from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 30-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was report.
COMPLETED
161 participants
Baseline and 30-Day Follow-up
2023-07-03
Participant Flow
A total of 161 subjects were enrolled in this study. Of those enrolled, 158 subjects were dispensed a test article while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 155 subjects completed the study while 3 subjects were discontinued.
Participant milestones
| Measure |
Test (Investigational Lipid Eye Drop)
Subjects randomized to the Test eye drops throughout the entire duration of the study.
|
Control (Blink Tears Eye Drops)
Subjects that instilled the Control eye drops throughout the study
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
81
|
|
Overall Study
COMPLETED
|
75
|
80
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Test (Investigational Lipid Eye Drop)
Subjects randomized to the Test eye drops throughout the entire duration of the study.
|
Control (Blink Tears Eye Drops)
Subjects that instilled the Control eye drops throughout the study
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Scheduling Issues
|
0
|
1
|
Baseline Characteristics
Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients
Baseline characteristics by cohort
| Measure |
Test (Investigational Lipid Eye Drop)
n=77 Participants
Subjects randomized to the Test eye drops throughout the entire duration of the study.
|
Control (Blink Tears Eye Drops)
n=81 Participants
Subjects that instilled the Control eye drops throughout the study
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.8 Years
STANDARD_DEVIATION 14.51 • n=5 Participants
|
48.8 Years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
47.8 Years
STANDARD_DEVIATION 14.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
77 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 30-Day Follow-upPopulation: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
Subjective overall ocular comfort was assessed at baseline, and at the 30-Day follow-up using a Visual Analogue Scale (VAS) ranging from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 30-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was report.
Outcome measures
| Measure |
Test (Investigational Lipid Eye Drops)
n=63 Participants
Subjects that instilled the Test eye drops throughout the study.
|
Control (Blink Tears Eye Drops)
n=67 Participants
Subjects that instilled the Control eye drops throughout the study
|
|---|---|---|
|
Change From Baseline Ocular Comfort (30-Day)
|
21.4 Units on a scale
Standard Deviation 24.51
|
10.0 Units on a scale
Standard Deviation 26.01
|
SECONDARY outcome
Timeframe: Baseline and 7-Day Follow-upPopulation: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
Subjective overall ocular comfort was assessed at baseline, and at the 7-Day follow-up using a Visual Analogue Scale (VAS) ranging from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 7-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was report.
Outcome measures
| Measure |
Test (Investigational Lipid Eye Drops)
n=63 Participants
Subjects that instilled the Test eye drops throughout the study.
|
Control (Blink Tears Eye Drops)
n=67 Participants
Subjects that instilled the Control eye drops throughout the study
|
|---|---|---|
|
Change From Baseline Ocular Comfort (7-Day)
|
14.3 Units on a scale
Standard Deviation 24.02
|
11.7 Units on a scale
Standard Deviation 21.23
|
SECONDARY outcome
Timeframe: 7-Day Follow-up and 30-Day Follow-upPopulation: All subjects/eyes who were that administered any test article excluding subjects who dropped out prior to administering any test article.
Subjects were reported whether they experienced any ocular symptoms, problems or complaints (yes/no) by eye. Ocular symptoms were assessed for each subject eye at all study visits (scheduled and unscheduled). The number of eyes that experience ocular symptoms or complaints was reported for the 7- and 30-Day follow-up.
Outcome measures
| Measure |
Test (Investigational Lipid Eye Drops)
n=154 Eyes
Subjects that instilled the Test eye drops throughout the study.
|
Control (Blink Tears Eye Drops)
n=162 Eyes
Subjects that instilled the Control eye drops throughout the study
|
|---|---|---|
|
Number of Subject Eyes That Reported Ocular Symptoms
7-Day Follow-up
|
33 Eyes
|
37 Eyes
|
|
Number of Subject Eyes That Reported Ocular Symptoms
30-Day Follow-up
|
21 Eyes
|
21 Eyes
|
SECONDARY outcome
Timeframe: 7-Day Follow-up and 30-Day Follow-upPopulation: All subjects who were administered any test article excluding subjects who dropped out prior to administering any test article.
Corneal staining was analyzed using the FDA grading scale (ie, Grade 0 = None, Grade 1 = Trace, Grade 2 = Mild, Grade 3 = Moderate and Grade 4 = Severe). These responses were categorized into a binary outcome as 1 if any Grade 2 or higher corneal staining was observed or otherwise 0 is recorded. Subjects with multiple events were counted only once for the analysis purpose.
Outcome measures
| Measure |
Test (Investigational Lipid Eye Drops)
n=154 Eyes
Subjects that instilled the Test eye drops throughout the study.
|
Control (Blink Tears Eye Drops)
n=162 Eyes
Subjects that instilled the Control eye drops throughout the study
|
|---|---|---|
|
Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining
7-Day Follow-up
|
1 Eyes
|
2 Eyes
|
|
Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining
30-Day Follow-up
|
2 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: Baseline and 7 Day-Day Follow-upPopulation: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
Subjective overall ocular vision was assessed at baseline, dispensing and 7-Day follow-up using a Visual Analogue Scale (VAS) from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular vision score was calculated as 7-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline vision scores indicates better performance. The average change from baseline vision score for each Arm was report.
Outcome measures
| Measure |
Test (Investigational Lipid Eye Drops)
n=63 Participants
Subjects that instilled the Test eye drops throughout the study.
|
Control (Blink Tears Eye Drops)
n=67 Participants
Subjects that instilled the Control eye drops throughout the study
|
|---|---|---|
|
Change From Baseline Ocular Vision (7-Day)
|
13.3 Units on a scale
Standard Deviation 23.23
|
5.2 Units on a scale
Standard Deviation 19.23
|
SECONDARY outcome
Timeframe: Baseline and 30 Day Follow-upPopulation: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
Subjective overall ocular vision was assessed at baseline, dispensing and 30 Day follow-up using a Visual Analogue Scale (VAS) from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular vision score was calculated as 30-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline vision scores indicates better performance. The average change from baseline vision score for each Arm was report.
Outcome measures
| Measure |
Test (Investigational Lipid Eye Drops)
n=63 Participants
Subjects that instilled the Test eye drops throughout the study.
|
Control (Blink Tears Eye Drops)
n=67 Participants
Subjects that instilled the Control eye drops throughout the study
|
|---|---|---|
|
Change From Baseline Ocular Vision (30-Day)
|
14.2 Units on a scale
Standard Deviation 22.52
|
4.9 Units on a scale
Standard Deviation 21.55
|
Adverse Events
Test (Investigational Lipid Eye Drop)
Control (Blink Tears Eye Drops)
Serious adverse events
| Measure |
Test (Investigational Lipid Eye Drop)
n=77 participants at risk
Subjects randomized to the Test eye drops throughout the entire duration of the study.
|
Control (Blink Tears Eye Drops)
n=81 participants at risk
Subjects that instilled the Control eye drops throughout the study
|
|---|---|---|
|
Injury, poisoning and procedural complications
Corneal Edema Due to Trauma
|
1.3%
1/77 • Number of events 1 • Throught the entire duration of the study. Approximately 30 Days per subject.
|
0.00%
0/81 • Throught the entire duration of the study. Approximately 30 Days per subject.
|
|
Metabolism and nutrition disorders
Pancreatitis
|
0.00%
0/77 • Throught the entire duration of the study. Approximately 30 Days per subject.
|
1.2%
1/81 • Number of events 1 • Throught the entire duration of the study. Approximately 30 Days per subject.
|
Other adverse events
Adverse event data not reported
Additional Information
Meredith Bishop, OD, MS, FAAO - Sr. Principal Research Optometrist
Johnson & Johnson Vision
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60