Trial Outcomes & Findings for A Study of ADX-102 in Subjects With Allergic Conjunctivitis (NCT NCT03012165)
NCT ID: NCT03012165
Last Updated: 2023-01-09
Results Overview
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Results posted on
2023-01-09
Participant Flow
Participant milestones
| Measure |
ADX-102 Ophthalmic Drops (0.5%)
ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
|
ADX-102 Ophthalmic Drops (0.1%)
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
|
Vehicle of ADX-102 Ophthalmic Drops
Vehicle of ADX-102 Ophthalmic Drops
Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
51
|
50
|
|
Overall Study
COMPLETED
|
51
|
49
|
49
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of ADX-102 in Subjects With Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
ADX-102 Ophthalmic Drops (0.5%)
n=53 Participants
ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
|
ADX-102 Ophthalmic Drops (0.1%)
n=51 Participants
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
|
Vehicle of ADX-102 Ophthalmic Drops
n=50 Participants
Vehicle of ADX-102 Ophthalmic Drops
Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
68 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Iris Color (Right Eye)
Blue
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Iris Color (Right Eye)
Brown
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
26 participants
n=5 Participants
|
86 participants
n=4 Participants
|
|
Iris Color (Right Eye)
Hazel
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Iris Color (Right Eye)
Green
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Iris Color (Right Eye)
Gray
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Iris Color (Right Eye)
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Iris Color (Left Eye)
Black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Iris Color (Left Eye)
Blue
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Iris Color (Left Eye)
Brown
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
26 participants
n=5 Participants
|
86 participants
n=4 Participants
|
|
Iris Color (Left Eye)
Hazel
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Iris Color (Left Eye)
Green
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Iris Color (Left Eye)
Gray
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Iris Color (Left Eye)
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.Population: Intent to treat population with observed data only.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Outcome measures
| Measure |
ADX-102 (0.5%)
n=51 Participants
ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
|
ADX-102 (0.1%)
n=49 Participants
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
|
Vehicle
n=49 Participants
Vehicle of ADX-102 Ophthalmic Drops
Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
|
|---|---|---|---|
|
Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
|
2.020 units on a scale
Standard Deviation 0.9821
|
2.398 units on a scale
Standard Deviation 0.8290
|
2.515 units on a scale
Standard Deviation 0.9661
|
PRIMARY outcome
Timeframe: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.Population: Intent to treat population with observed data only.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Outcome measures
| Measure |
ADX-102 (0.5%)
n=51 Participants
ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
|
ADX-102 (0.1%)
n=49 Participants
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
|
Vehicle
n=49 Participants
Vehicle of ADX-102 Ophthalmic Drops
Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
|
|---|---|---|---|
|
Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
|
1.662 units on a scale
Standard Deviation 1.0085
|
1.801 units on a scale
Standard Deviation 0.9601
|
1.985 units on a scale
Standard Deviation 0.9768
|
PRIMARY outcome
Timeframe: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.Population: Intent to treat with observed data only.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Outcome measures
| Measure |
ADX-102 (0.5%)
n=51 Participants
ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
|
ADX-102 (0.1%)
n=49 Participants
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
|
Vehicle
n=49 Participants
Vehicle of ADX-102 Ophthalmic Drops
Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
|
|---|---|---|---|
|
Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
|
1.152 units on a scale
Standard Deviation 0.9799
|
1.434 units on a scale
Standard Deviation 0.9773
|
1.551 units on a scale
Standard Deviation 1.0433
|
Adverse Events
ADX-102 Ophthalmic Drops (0.5%)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ADX-102 Ophthalmic Drops (0.1%)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle of ADX-102 Ophthalmic Drops
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr. Director, Clinical Operations
Aldeyra Therapeutics, Inc.
Phone: 781-257-3063
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place