Trial Outcomes & Findings for Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (NCT NCT04201574)
NCT ID: NCT04201574
Last Updated: 2023-06-22
Results Overview
Subjects reporting any treatment-emergent adverse events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
138 participants
Primary outcome timeframe
8 weeks
Results posted on
2023-06-22
Participant Flow
8 investigational sites in the United States
Participant milestones
| Measure |
Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution (control arm)
|
ALY688 Ophthalmic Solution 0.1%
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
ALY688 Ophthalmic Solution Concentration 2
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
46
|
|
Overall Study
COMPLETED
|
46
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Vehicle Ophthalmic Solution
n=46 Participants
Vehicle Ophthalmic Solution (control)
|
ALY688 Ophthalmic Solution 0.1%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 2
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.0 years
n=5 Participants
|
63.0 years
n=7 Participants
|
64.5 years
n=5 Participants
|
63.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 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
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Eye Dryness Score
|
66.39 units on a scale
STANDARD_DEVIATION 14.353 • n=5 Participants
|
67.28 units on a scale
STANDARD_DEVIATION 12.715 • n=7 Participants
|
64.48 units on a scale
STANDARD_DEVIATION 11.407 • n=5 Participants
|
66.05 units on a scale
STANDARD_DEVIATION 12.841 • n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Safety Population
Subjects reporting any treatment-emergent adverse events
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=46 Participants
Vehicle Ophthalmic Solution (control arm)
|
ALY688 Ophthalmic Solution 0.1%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 2
|
|---|---|---|---|
|
Number of Subjects With Adverse Events
|
13 Participants
|
15 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: mITT Population
Mean change from baseline in eye dryness score (7-day average) using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=46 Participants
Vehicle Ophthalmic Solution (control arm)
|
ALY688 Ophthalmic Solution 0.1%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 2
|
|---|---|---|---|
|
Eye Dryness Score (7-Day Average)
|
-6.48 units on a scale
Standard Error 2.62
|
-5.66 units on a scale
Standard Error 2.62
|
-11.14 units on a scale
Standard Error 2.64
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: mITT Population
Mean change from baseline in zonal corneal fluorescein staining score in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=46 Participants
Vehicle Ophthalmic Solution (control arm)
|
ALY688 Ophthalmic Solution 0.1%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 2
|
|---|---|---|---|
|
Corneal Fluorescein Staining
Zone 1
|
-0.33 units on a scale
Standard Error 0.10
|
-0.37 units on a scale
Standard Error 0.10
|
-0.51 units on a scale
Standard Error 0.10
|
|
Corneal Fluorescein Staining
Zone 2
|
-0.31 units on a scale
Standard Error 0.08
|
-0.21 units on a scale
Standard Error 0.08
|
-0.36 units on a scale
Standard Error 0.08
|
|
Corneal Fluorescein Staining
Zone 3
|
-0.44 units on a scale
Standard Error 0.09
|
-0.45 units on a scale
Standard Error 0.09
|
-0.51 units on a scale
Standard Error 0.09
|
|
Corneal Fluorescein Staining
Zone 4
|
-0.40 units on a scale
Standard Error 0.12
|
-0.43 units on a scale
Standard Error 0.11
|
-0.67 units on a scale
Standard Error 0.12
|
|
Corneal Fluorescein Staining
Zone 5
|
-0.54 units on a scale
Standard Error 0.13
|
-0.42 units on a scale
Standard Error 0.13
|
-0.81 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Modified Intent-to-Treat (mITT) Population
Mean change from baseline in ocular discomfort score of 7-day average using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=46 Participants
Vehicle Ophthalmic Solution (control arm)
|
ALY688 Ophthalmic Solution 0.1%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 2
|
|---|---|---|---|
|
Ocular Discomfort Score by Visual Analog Scale
|
-8.19 units on a scale
Standard Deviation 16.314
|
-4.47 units on a scale
Standard Deviation 17.310
|
-8.62 units on a scale
Standard Deviation 23.926
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: mITT Population
Mean change from baseline in Symptom Assessment in Dry Eye global symptom score on a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse. Global symptom score is calculated as the square root of the frequency score time the severity score per visit
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=46 Participants
Vehicle Ophthalmic Solution (control arm)
|
ALY688 Ophthalmic Solution 0.1%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 2
|
|---|---|---|---|
|
Symptom Assessment in Dry Eye (SAnDE) Score Assessment
|
-13.76 units on a scale
Standard Deviation 19.247
|
-6.76 units on a scale
Standard Deviation 16.840
|
-15.48 units on a scale
Standard Deviation 25.219
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: mITT Population
Mean change from baseline in zonal conjunctival lissamine green staining in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=46 Participants
Vehicle Ophthalmic Solution (control arm)
|
ALY688 Ophthalmic Solution 0.1%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 2
|
|---|---|---|---|
|
Conjunctival Lissamine Green Staining
Zone 1
|
0.12 units on a scale
Standard Error 0.10
|
-0.13 units on a scale
Standard Error 0.10
|
-0.18 units on a scale
Standard Error 0.10
|
|
Conjunctival Lissamine Green Staining
Zone 2
|
-0.04 units on a scale
Standard Error 0.11
|
-0.25 units on a scale
Standard Error 0.11
|
-0.31 units on a scale
Standard Error 0.11
|
|
Conjunctival Lissamine Green Staining
Zone 3
|
0.02 units on a scale
Standard Error 0.12
|
-0.15 units on a scale
Standard Error 0.11
|
-0.26 units on a scale
Standard Error 0.12
|
|
Conjunctival Lissamine Green Staining
Zone 4
|
-0.22 units on a scale
Standard Error 0.11
|
-0.37 units on a scale
Standard Error 0.11
|
-0.22 units on a scale
Standard Error 0.11
|
|
Conjunctival Lissamine Green Staining
Zone 5
|
-0.17 units on a scale
Standard Error 0.13
|
-0.32 units on a scale
Standard Error 0.12
|
-0.31 units on a scale
Standard Error 0.13
|
|
Conjunctival Lissamine Green Staining
Zone 6
|
0.00 units on a scale
Standard Error 0.14
|
-0.02 units on a scale
Standard Error 0.13
|
-0.15 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: mITT Population
Mean change from baseline in zonal conjunctival hyperemia in study eye using a 0- to 4-unit clinical grading scale and standardized grading photos, with 0 being better and 4 being worse
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=46 Participants
Vehicle Ophthalmic Solution (control arm)
|
ALY688 Ophthalmic Solution 0.1%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 2
|
|---|---|---|---|
|
Conjunctival Hyperemia Grading
Frontal
|
-0.17 units on a scale
Standard Error 0.07
|
-0.15 units on a scale
Standard Error 0.07
|
-0.13 units on a scale
Standard Error 0.07
|
|
Conjunctival Hyperemia Grading
Nasal
|
-0.20 units on a scale
Standard Error 0.07
|
-0.13 units on a scale
Standard Error 0.07
|
-0.24 units on a scale
Standard Error 0.07
|
|
Conjunctival Hyperemia Grading
Temporal
|
-0.18 units on a scale
Standard Error 0.08
|
-0.08 units on a scale
Standard Error 0.08
|
-0.21 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 8 weeksMean change from baseline in TBUT in study eye
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=46 Participants
Vehicle Ophthalmic Solution (control arm)
|
ALY688 Ophthalmic Solution 0.1%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 2
|
|---|---|---|---|
|
Tear Film Break-up Time (TBUT)
|
0.29 seconds
Standard Error 0.26
|
0.13 seconds
Standard Error 0.25
|
0.18 seconds
Standard Error 0.26
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: PP Population
Mean change from baseline in tear volume in study eye as assessed by unanesthetized Schirmer test
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=46 Participants
Vehicle Ophthalmic Solution (control arm)
|
ALY688 Ophthalmic Solution 0.1%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
n=46 Participants
ALY688 Ophthalmic Solution Concentration 2
|
|---|---|---|---|
|
Schirmer's Test
|
1.64 mm
Standard Error 0.94
|
1.92 mm
Standard Error 0.91
|
2.50 mm
Standard Error 0.93
|
Adverse Events
Vehicle Ophthalmic Solution
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
ALY688 Ophthalmic Solution 0.1%
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
ALY688 Ophthalmic Solution 0.4%
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vehicle Ophthalmic Solution
n=46 participants at risk
Vehicle Ophthalmic Solution (control arm)
|
ALY688 Ophthalmic Solution 0.1%
n=46 participants at risk
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
n=46 participants at risk
ALY688 Ophthalmic Solution Concentration 2
|
|---|---|---|---|
|
Vascular disorders
vascular pseudoaneurysm
|
0.00%
0/46 • Duration of study (8 weeks)
|
2.2%
1/46 • Number of events 1 • Duration of study (8 weeks)
|
0.00%
0/46 • Duration of study (8 weeks)
|
Other adverse events
| Measure |
Vehicle Ophthalmic Solution
n=46 participants at risk
Vehicle Ophthalmic Solution (control arm)
|
ALY688 Ophthalmic Solution 0.1%
n=46 participants at risk
ALY688 Ophthalmic Solution Concentration 1
|
ALY688 Ophthalmic Solution 0.4%
n=46 participants at risk
ALY688 Ophthalmic Solution Concentration 2
|
|---|---|---|---|
|
General disorders
Instillation site pain
|
19.6%
9/46 • Number of events 18 • Duration of study (8 weeks)
|
13.0%
6/46 • Number of events 12 • Duration of study (8 weeks)
|
13.0%
6/46 • Number of events 12 • Duration of study (8 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60