Trial Outcomes & Findings for OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis (NCT NCT02445326)
NCT ID: NCT02445326
Last Updated: 2018-03-29
Results Overview
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
73 participants
Primary outcome timeframe
3 minutes
Results posted on
2018-03-29
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
|
35
|
38
|
|
Overall Study
COMPLETED
|
33
|
37
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OTX-14-007: 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=35 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=38 Participants
PV (placebo drug delivery vehicle)
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.2 years
n=99 Participants
|
36.3 years
n=107 Participants
|
37 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Iris Color
Blue
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Iris Color
Brown
|
26 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Iris Color
Hazel
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Iris Color
Green
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 minutesModified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Outcome measures
| Measure |
OTX-DP
n=35 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=38 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
|
1.68 units on a scale
Standard Deviation 1.032
|
2.66 units on a scale
Standard Deviation 0.861
|
PRIMARY outcome
Timeframe: 5 minutesModified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Outcome measures
| Measure |
OTX-DP
n=35 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=38 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
|
1.87 units on a scale
Standard Deviation 1.040
|
2.74 units on a scale
Standard Deviation 0.690
|
PRIMARY outcome
Timeframe: 7 minutesModified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Outcome measures
| Measure |
OTX-DP
n=35 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=38 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
|
1.70 units on a scale
Standard Deviation 0.938
|
2.74 units on a scale
Standard Deviation 0.679
|
PRIMARY outcome
Timeframe: 7 minutesModified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Outcome measures
| Measure |
OTX-DP
n=35 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=38 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
|
1.52 units on a scale
Standard Deviation 0.641
|
1.80 units on a scale
Standard Deviation 0.764
|
PRIMARY outcome
Timeframe: 15 minutesModified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Outcome measures
| Measure |
OTX-DP
n=35 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=38 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
|
1.48 units on a scale
Standard Deviation 0.698
|
1.75 units on a scale
Standard Deviation 0.786
|
PRIMARY outcome
Timeframe: 20 minutesModified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Outcome measures
| Measure |
OTX-DP
n=35 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=38 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
|
1.44 units on a scale
Standard Deviation 0.710
|
1.76 units on a scale
Standard Deviation 0.766
|
Adverse Events
OTX-DP
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Vehicle
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 |
OTX-DP
n=35 participants at risk
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=38 participants at risk
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
General disorders
Adverse Events
|
8.6%
3/35 • Number of events 4
|
10.5%
4/38 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place