Trial Outcomes & Findings for Clinical Evaluation of a Multidose Preservative-free Lubricating Eye Drops Contained in Novelia® Eye Dropper in Non-Contact Lens Wearing Patients (NCT NCT05661851)
NCT ID: NCT05661851
Last Updated: 2025-04-27
Results Overview
Subjective ocular comfort was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale 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 reported.
COMPLETED
PHASE2
121 participants
Baseline and 30-Day Follow-up
2025-04-27
Participant Flow
A total of 121 subjects were enrolled in this study. Of those enrolled, 118 subjects were dispensed at least one study eyedrop while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 107 subjects completed the study while 11 subjects were discontinued.
Participant milestones
| Measure |
Test
Subjects that were randomized to the Test group throughout the duration of the study.
|
Control
Subjects that were randomized to the Control group throughout the duration of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
60
|
|
Overall Study
COMPLETED
|
53
|
54
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Test
Subjects that were randomized to the Test group throughout the duration of the study.
|
Control
Subjects that were randomized to the Control group throughout the duration of the study.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Covid-19 Related
|
3
|
4
|
|
Overall Study
investigational product Was Dispensed Incorrectly At Visit 2
|
1
|
0
|
|
Overall Study
The Patient Was Dispensed The Incorrect investigational product At Visit 2
|
0
|
1
|
Baseline Characteristics
Clinical Evaluation of a Multidose Preservative-free Lubricating Eye Drops Contained in Novelia® Eye Dropper in Non-Contact Lens Wearing Patients
Baseline characteristics by cohort
| Measure |
Test
n=58 Participants
Subjects that were randomized to the Test group throughout the duration of the study.
|
Control
n=60 Participants
Subjects that were randomized to the Control group throughout the duration of the study.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.2 Years
STANDARD_DEVIATION 14.23 • n=99 Participants
|
50.1 Years
STANDARD_DEVIATION 13.79 • n=107 Participants
|
49.2 Years
STANDARD_DEVIATION 13.98 • n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 30-Day Follow-upPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
Subjective ocular comfort was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale 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 reported.
Outcome measures
| Measure |
Test
n=53 Participants
Subjects that were randomized to the Test group throughout the duration of the study.
|
Control
n=54 Participants
Subjects that were randomized to the Control group throughout the duration of the study.
|
|---|---|---|
|
Change in Overall Quality of Ocular Comfort From Baseline to 30-Day Follow-Up Using VAS Scores
|
18.47 Scores on a scale
Standard Deviation 22.125
|
9.65 Scores on a scale
Standard Deviation 22.859
|
SECONDARY outcome
Timeframe: Baseline and 30-Day Follow-upPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
Subjective vision was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline quality of 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
n=53 Participants
Subjects that were randomized to the Test group throughout the duration of the study.
|
Control
n=54 Participants
Subjects that were randomized to the Control group throughout the duration of the study.
|
|---|---|---|
|
Change in Overall Quality of Vision From Baseline to 30-Day Follow-Up Using VAS Scores
|
11.55 Scores on a scale
Standard Deviation 22.863
|
5.70 Scores on a scale
Standard Deviation 23.615
|
Adverse Events
Test
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Research Optometrist
Johnson & Johnson Vision Care, Inc. (JJVC)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60