Trial Outcomes & Findings for IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease (NCT NCT06400459)
NCT ID: NCT06400459
Last Updated: 2026-02-12
Results Overview
Mean change from baseline in study eye in unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
150 participants
Primary outcome timeframe
29 Days
Results posted on
2026-02-12
Participant Flow
Participant milestones
| Measure |
IVW-1001 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%: IVW-1001 Ophthalmic Eyelid Wipe 0.1%
|
IVW-1001 0.2%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.2%: IVW-1001 Ophthalmic Eyelid Wipe 0.2%
|
IVW-1001 Placebo
Vehicle
IVW-1001 Placebo: IVW-1001 Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
48
|
49
|
|
Overall Study
COMPLETED
|
53
|
48
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
IVW-1001 0.1%
n=53 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%: IVW-1001 Ophthalmic Eyelid Wipe 0.1%
|
IVW-1001 0.2%
n=48 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.2%: IVW-1001 Ophthalmic Eyelid Wipe 0.2%
|
IVW-1001 Placebo
n=49 Participants
Vehicle
IVW-1001 Placebo: IVW-1001 Placebo
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 11.19 • n=41 Participants
|
63.5 years
STANDARD_DEVIATION 12.07 • n=1581 Participants
|
68.1 years
STANDARD_DEVIATION 11.43 • n=4626 Participants
|
65.1 years
STANDARD_DEVIATION 11.57 • n=72 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=41 Participants
|
38 Participants
n=1581 Participants
|
39 Participants
n=4626 Participants
|
113 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=41 Participants
|
10 Participants
n=1581 Participants
|
10 Participants
n=4626 Participants
|
37 Participants
n=72 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
4 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
16 Participants
n=4626 Participants
|
42 Participants
n=72 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=41 Participants
|
34 Participants
n=1581 Participants
|
31 Participants
n=4626 Participants
|
101 Participants
n=72 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=41 Participants
|
48 Participants
n=1581 Participants
|
49 Participants
n=4626 Participants
|
150 Participants
n=72 Participants
|
|
Unanesthetized Schirmer test (Study Eye)
|
6.8 mm
STANDARD_DEVIATION 1.98 • n=41 Participants
|
6.1 mm
STANDARD_DEVIATION 1.87 • n=1581 Participants
|
6.7 mm
STANDARD_DEVIATION 1.92 • n=4626 Participants
|
6.5 mm
STANDARD_DEVIATION 1.93 • n=72 Participants
|
|
Total Corneal Fluorescein Staining Score in the Study Eye (0, none to 20, severe)
|
6.5 Score on a scale
STANDARD_DEVIATION 1.37 • n=41 Participants
|
6.8 Score on a scale
STANDARD_DEVIATION 1.72 • n=1581 Participants
|
6.8 Score on a scale
STANDARD_DEVIATION 1.48 • n=4626 Participants
|
6.7 Score on a scale
STANDARD_DEVIATION 1.53 • n=72 Participants
|
|
Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score (0, none, to 100, severe)
|
61.1 Score on a scale
STANDARD_DEVIATION 23.3 • n=41 Participants
|
62.6 Score on a scale
STANDARD_DEVIATION 21.1 • n=1581 Participants
|
61.9 Score on a scale
STANDARD_DEVIATION 23.0 • n=4626 Participants
|
61.8 Score on a scale
STANDARD_DEVIATION 22.5 • n=72 Participants
|
|
Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score
|
54.9 Score on a scale
STANDARD_DEVIATION 23.1 • n=41 Participants
|
54.0 Score on a scale
STANDARD_DEVIATION 20.2 • n=1581 Participants
|
55.0 Score on a scale
STANDARD_DEVIATION 22.5 • n=4626 Participants
|
54.6 Score on a scale
STANDARD_DEVIATION 21.9 • n=72 Participants
|
|
Symptom Assessment in Dry Eye (SANDE): Global Score
|
57.5 Score on a scale
STANDARD_DEVIATION 22.1 • n=41 Participants
|
57.5 Score on a scale
STANDARD_DEVIATION 23.1 • n=1581 Participants
|
57.5 Score on a scale
STANDARD_DEVIATION 22.1 • n=4626 Participants
|
57.5 Score on a scale
STANDARD_DEVIATION 22.4 • n=72 Participants
|
PRIMARY outcome
Timeframe: 29 DaysMean change from baseline in study eye in unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness)
Outcome measures
| Measure |
IVW-1001 0.1%
n=52 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%: IVW-1001 Ophthalmic Eyelid Wipe 0.1%
|
IVW-1001 0.2%
n=47 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.2%: IVW-1001 Ophthalmic Eyelid Wipe 0.2%
|
IVW-1001 Placebo
n=48 Participants
Vehicle
IVW-1001 Placebo: IVW-1001 Placebo
|
|---|---|---|---|
|
Schirmer's
|
1.3 mm
Standard Deviation 6.40
|
2.1 mm
Standard Deviation 6.64
|
0.9 mm
Standard Deviation 5.24
|
SECONDARY outcome
Timeframe: 29 DaysMean change from baseline in best corrected visual acuity
Outcome measures
| Measure |
IVW-1001 0.1%
n=53 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%: IVW-1001 Ophthalmic Eyelid Wipe 0.1%
|
IVW-1001 0.2%
n=48 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.2%: IVW-1001 Ophthalmic Eyelid Wipe 0.2%
|
IVW-1001 Placebo
n=49 Participants
Vehicle
IVW-1001 Placebo: IVW-1001 Placebo
|
|---|---|---|---|
|
Visual Acuity
|
-0.007 Logarithm of Minimum Angle of Resolution
Standard Deviation 0.0739
|
-0.013 Logarithm of Minimum Angle of Resolution
Standard Deviation 0.0625
|
-0.014 Logarithm of Minimum Angle of Resolution
Standard Deviation 0.0728
|
SECONDARY outcome
Timeframe: Week 4Population: Modified Intent to Treat
Change from baseline in score on a scale (0 - none - to 20 - severe)
Outcome measures
| Measure |
IVW-1001 0.1%
n=53 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%: IVW-1001 Ophthalmic Eyelid Wipe 0.1%
|
IVW-1001 0.2%
n=48 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.2%: IVW-1001 Ophthalmic Eyelid Wipe 0.2%
|
IVW-1001 Placebo
n=49 Participants
Vehicle
IVW-1001 Placebo: IVW-1001 Placebo
|
|---|---|---|---|
|
Total Corneal Fluorescein Staining Score in the Study Eye
|
-1.65 Score on a scale
Standard Deviation 0.24
|
-1.80 Score on a scale
Standard Deviation 0.25
|
-1.10 Score on a scale
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Week 4Population: modified Intent to Treat
Change from Baseline in the SANDE visual analog scale (0 - none to 100 - severe)
Outcome measures
| Measure |
IVW-1001 0.1%
n=53 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%: IVW-1001 Ophthalmic Eyelid Wipe 0.1%
|
IVW-1001 0.2%
n=48 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.2%: IVW-1001 Ophthalmic Eyelid Wipe 0.2%
|
IVW-1001 Placebo
n=49 Participants
Vehicle
IVW-1001 Placebo: IVW-1001 Placebo
|
|---|---|---|---|
|
Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score
|
-5.77 Score on a scale
Standard Deviation 2.91
|
-23.57 Score on a scale
Standard Deviation 3.06
|
-9.88 Score on a scale
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: modified intent-to-treat
Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe)
Outcome measures
| Measure |
IVW-1001 0.1%
n=53 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%: IVW-1001 Ophthalmic Eyelid Wipe 0.1%
|
IVW-1001 0.2%
n=48 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.2%: IVW-1001 Ophthalmic Eyelid Wipe 0.2%
|
IVW-1001 Placebo
n=49 Participants
Vehicle
IVW-1001 Placebo: IVW-1001 Placebo
|
|---|---|---|---|
|
Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score
|
-8.73 Score on a scale
Standard Deviation 2.78
|
-22.80 Score on a scale
Standard Deviation 2.93
|
-12.55 Score on a scale
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Modified Intent to treat
Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe)
Outcome measures
| Measure |
IVW-1001 0.1%
n=53 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%: IVW-1001 Ophthalmic Eyelid Wipe 0.1%
|
IVW-1001 0.2%
n=48 Participants
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.2%: IVW-1001 Ophthalmic Eyelid Wipe 0.2%
|
IVW-1001 Placebo
n=49 Participants
Vehicle
IVW-1001 Placebo: IVW-1001 Placebo
|
|---|---|---|---|
|
Symptom Assessment in Dry Eye (SANDE): Global Score
|
-7.11 Score on a scale
Standard Deviation 2.70
|
-23.36 Score on a scale
Standard Deviation 2.84
|
-11.16 Score on a scale
Standard Deviation 2.86
|
Adverse Events
IVW-1001 0.1%
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
IVW-1001 0.2%
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
IVW-1001 Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IVW-1001 0.1%
n=53 participants at risk
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%: IVW-1001 Ophthalmic Eyelid Wipe 0.1%
|
IVW-1001 0.2%
n=48 participants at risk
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.2%: IVW-1001 Ophthalmic Eyelid Wipe 0.2%
|
IVW-1001 Placebo
n=49 participants at risk
Vehicle
IVW-1001 Placebo: IVW-1001 Placebo
|
|---|---|---|---|
|
Eye disorders
Eye disorders
|
5.7%
3/53 • Number of events 3 • Week 4
|
10.4%
5/48 • Number of events 5 • Week 4
|
8.2%
4/49 • Number of events 4 • Week 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators to collaborate with Sponsor on publication.
- Publication restrictions are in place
Restriction type: OTHER