Trial Outcomes & Findings for Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease (NCT NCT06444516)
NCT ID: NCT06444516
Last Updated: 2026-02-18
Results Overview
The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, the subject selected a single response for both eyes, where 0=I did not have this symptom/Not applicable; 1=I had this symptom and it bothered me not at all; 2=I had this symptom and it bothered me slightly; 3=I had this symptom and it bothered me moderately; and 4=I had this symptom and it bothered me very much. The overall Symptom Bother score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25 and ranged from 0 (minimum) to 100 (maximum). Baseline was defined as the last non-missing value prior to the start date of the study treatment. Change from baseline was calculated as Day 30 minus baseline. A negative change value represents an improvement (less symptom bother).
COMPLETED
NA
188 participants
Baseline (Day 1); Day 30
2026-02-18
Participant Flow
Subjects were recruited from 9 investigative sites located in the United States.
Of the 188 subjects enrolled in the study (consented), 27 were exited as screen failures. This reporting group includes all subjects exposed to the study product (161).
Participant milestones
| Measure |
FID123300
One drop of FID123300 ocular lubricant in each eye on Day 1 in the morning, followed by at least one drop in each eye 4 times a day on Days 2-30
|
|---|---|
|
Overall Study
STARTED
|
161
|
|
Overall Study
COMPLETED
|
158
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
FID123300
One drop of FID123300 ocular lubricant in each eye on Day 1 in the morning, followed by at least one drop in each eye 4 times a day on Days 2-30
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
Baseline Characteristics
Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
FID123300
n=161 Participants
One drop of FID123300 ocular lubricant in each eye on Day 1 in the morning, followed by at least one drop in each eye 4 times a day on Days 2-30
|
|---|---|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 14.7 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
121 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
39 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
139 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
138 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
161 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1); Day 30Population: Safety Analysis Set with data at both visits
The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, the subject selected a single response for both eyes, where 0=I did not have this symptom/Not applicable; 1=I had this symptom and it bothered me not at all; 2=I had this symptom and it bothered me slightly; 3=I had this symptom and it bothered me moderately; and 4=I had this symptom and it bothered me very much. The overall Symptom Bother score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25 and ranged from 0 (minimum) to 100 (maximum). Baseline was defined as the last non-missing value prior to the start date of the study treatment. Change from baseline was calculated as Day 30 minus baseline. A negative change value represents an improvement (less symptom bother).
Outcome measures
| Measure |
FID123300
n=158 Participants
One drop of FID123300 ocular lubricant in each eye on Day 1 in the morning, followed by at least one drop in each eye 4 times a day on Days 2-30
|
|---|---|
|
Change From Baseline in Impact of Dry Eye on Everyday Life - Symptom Bother (IDEEL-SB) Questionnaire Score at Day 30
|
-16.95 score on a scale
Standard Deviation 13.12
|
Adverse Events
FID123300
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr. Principal I, Clinical Project Management
Alcon Research, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER