Trial Outcomes & Findings for OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis (NCT NCT02988882)
NCT ID: NCT02988882
Last Updated: 2020-10-12
Results Overview
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
86 participants
Primary outcome timeframe
3 minutes
Results posted on
2020-10-12
Participant Flow
Participant milestones
| Measure |
OTX-DP
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
42
|
|
Overall Study
COMPLETED
|
41
|
40
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
OTX-DP
n=44 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=42 Participants
PV (placebo drug delivery vehicle)
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.1 years
n=5 Participants
|
42.2 years
n=7 Participants
|
40 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Iris Color
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Iris Color
Blue
|
6 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Iris Color
Brown
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Iris Color
Hazel
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Iris Color
Green
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 minutesModified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Outcome measures
| Measure |
OTX-DP
n=44 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=42 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
|
2.04 units on a scale
Standard Deviation 1.088
|
2.31 units on a scale
Standard Deviation 1.115
|
PRIMARY outcome
Timeframe: 5 minutesModified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Outcome measures
| Measure |
OTX-DP
n=44 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=42 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6
|
2.07 units on a scale
Standard Deviation 1.100
|
2.41 units on a scale
Standard Deviation 1.039
|
PRIMARY outcome
Timeframe: 7 minutesModified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Outcome measures
| Measure |
OTX-DP
n=44 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=42 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
|
2.02 units on a scale
Standard Deviation 1.131
|
2.37 units on a scale
Standard Deviation 1.129
|
Adverse Events
OTX-DP
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Vehicle
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OTX-DP
n=41 participants at risk
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=40 participants at risk
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
General disorders
Adverse Events
|
14.6%
6/41 • Number of events 7
|
27.5%
11/40 • Number of events 17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place