Trial Outcomes & Findings for Tavilermide Ophthalmic Solution for the Treatment of Dry Eye (NCT NCT03925727)
NCT ID: NCT03925727
Last Updated: 2023-04-05
Results Overview
The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
623 participants
Primary outcome timeframe
Baseline to Day 85 in 5% Tavilermide versus Placebo
Results posted on
2023-04-05
Participant Flow
Participant milestones
| Measure |
Tavilermide 5%
Twice daily topical ocular dosing for 12 weeks
|
Tavilermide 1%
Twice daily topical ocular dosing for 12 weeks
|
Placebo
Twice daily topical ocular dosing for 12 weeks (vehicle)
|
|---|---|---|---|
|
Overall Study
STARTED
|
263
|
100
|
260
|
|
Overall Study
COMPLETED
|
244
|
94
|
242
|
|
Overall Study
NOT COMPLETED
|
19
|
6
|
18
|
Reasons for withdrawal
| Measure |
Tavilermide 5%
Twice daily topical ocular dosing for 12 weeks
|
Tavilermide 1%
Twice daily topical ocular dosing for 12 weeks
|
Placebo
Twice daily topical ocular dosing for 12 weeks (vehicle)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
3
|
|
Overall Study
Protocol Violation
|
1
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
4
|
|
Overall Study
Administrative Reasons
|
3
|
1
|
2
|
|
Overall Study
Randomized in error or Disqualified
|
8
|
1
|
7
|
Baseline Characteristics
Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Baseline characteristics by cohort
| Measure |
Tavilermide 5%
n=257 Participants
Tavilermide ophthalmic solution: BID topical dosing
|
Tavilermide 1%
n=97 Participants
Tavilermide ophthalmic solution: BID topical dosing
|
Vehicle
n=253 Participants
Placebo: BID topical dosing
|
Total
n=607 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.1 Years
STANDARD_DEVIATION 13.47 • n=5 Participants
|
59.7 Years
STANDARD_DEVIATION 14.63 • n=7 Participants
|
60.5 Years
STANDARD_DEVIATION 14.00 • n=5 Participants
|
60.6 Years
STANDARD_DEVIATION 13.87 • n=4 Participants
|
|
Sex: Female, Male
Female
|
201 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
465 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
142 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
232 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
544 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
219 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
513 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Eye Dryness Score
|
63.3 units on a scale
STANDARD_DEVIATION 20.38 • n=5 Participants
|
65.8 units on a scale
STANDARD_DEVIATION 19.06 • n=7 Participants
|
65.0 units on a scale
STANDARD_DEVIATION 20.22 • n=5 Participants
|
64.4 units on a scale
STANDARD_DEVIATION 20.10 • n=4 Participants
|
|
Total Corneal Fluorescein Staining
|
7.4 units on a scale
STANDARD_DEVIATION 1.92 • n=5 Participants
|
7.4 units on a scale
STANDARD_DEVIATION 1.77 • n=7 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 2.06 • n=5 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 1.96 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 85 in 5% Tavilermide versus PlaceboPopulation: ITT Population with Markov Chain Monte Carlo (MCMC) on all randomized subjects
The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm.
Outcome measures
| Measure |
Tavilermide 5%
n=257 Participants
BID topical ocular dosing
|
Tavilermide 1%
n=97 Participants
BID topical ocular dosing
|
Placebo
n=253 Participants
BID topical dosing (vehicle)
|
|---|---|---|---|
|
Change From Baseline in Eye Dryness Score as Measured by the VAS
|
-15.1 score on a scale
Standard Error 1.64
|
-20.6 score on a scale
Standard Error 2.66
|
-16.5 score on a scale
Standard Error 1.67
|
PRIMARY outcome
Timeframe: Baseline to Day 85 in 5% Tavilermide versus PlaceboPopulation: ITT Population with MCMC on all randomized subjects
The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior) . Grade 0 was specified when no staining is present. The maximum score was 15. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
Outcome measures
| Measure |
Tavilermide 5%
n=257 Participants
BID topical ocular dosing
|
Tavilermide 1%
n=97 Participants
BID topical ocular dosing
|
Placebo
n=253 Participants
BID topical dosing (vehicle)
|
|---|---|---|---|
|
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
|
-2.6 units on a scale
Standard Error 0.17
|
-2.3 units on a scale
Standard Error 0.28
|
-2.1 units on a scale
Standard Error 0.17
|
Adverse Events
Tavilermide 5%
Serious events: 2 serious events
Other events: 16 other events
Deaths: 1 deaths
Tavilermide 1%
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tavilermide 5%
n=261 participants at risk
Twice daily topical dosing
|
Tavilermide 1%
n=99 participants at risk
Twice daily topical dosing
|
Placebo
n=255 participants at risk
Twice daily topical dosing (vehicle)
|
|---|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.38%
1/261 • Number of events 1 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
0.00%
0/99 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
0.00%
0/255 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.38%
1/261 • Number of events 1 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
0.00%
0/99 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
0.00%
0/255 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/261 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
0.00%
0/99 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
0.39%
1/255 • Number of events 1 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/261 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
0.00%
0/99 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
0.39%
1/255 • Number of events 1 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/261 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
0.00%
0/99 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
0.39%
1/255 • Number of events 1 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
Other adverse events
| Measure |
Tavilermide 5%
n=261 participants at risk
Twice daily topical dosing
|
Tavilermide 1%
n=99 participants at risk
Twice daily topical dosing
|
Placebo
n=255 participants at risk
Twice daily topical dosing (vehicle)
|
|---|---|---|---|
|
General disorders
Instillation site pain
|
6.1%
16/261 • Number of events 25 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
1.0%
1/99 • Number of events 1 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
3.1%
8/255 • Number of events 8 • 12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor, or its designee, shall have the right to coordinate one or more publications of the aggregate multi-site Study results. Accordingly, Investigator agrees not to publish or present the results of the Study until such time as the aggregate multi-site Study results are published.
- Publication restrictions are in place
Restriction type: OTHER