Trial Outcomes & Findings for OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye (NCT NCT02468700)
NCT ID: NCT02468700
Last Updated: 2018-03-29
Results Overview
National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Day 15
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
|
22
|
21
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye
Baseline characteristics by cohort
| Measure |
OTX-DP
n=22 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=21 Participants
PV (placebo drug delivery vehicle)
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
n=5 Participants
|
62.5 years
n=7 Participants
|
62.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Iris Color
Blue
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Iris Color
Brown
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Iris Color
Hazel
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Iris Color
Green
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)
Outcome measures
| Measure |
OTX-DP
n=22 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=21 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Total Corneal Fluorescein Staining
|
4.09 units on a scale
Standard Deviation 2.671
|
5.05 units on a scale
Standard Deviation 3.041
|
PRIMARY outcome
Timeframe: Day 30National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)
Outcome measures
| Measure |
OTX-DP
n=22 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=21 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Total Corneal Fluorescein Staining
|
4.64 units on a scale
Standard Deviation 2.361
|
6.38 units on a scale
Standard Deviation 3.278
|
PRIMARY outcome
Timeframe: Day 15National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)
Outcome measures
| Measure |
OTX-DP
n=22 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=21 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Total Conjunctival Lissamine Green Staining
|
4.36 units on a scale
Standard Deviation 2.517
|
5.67 units on a scale
Standard Deviation 4.199
|
PRIMARY outcome
Timeframe: Day 30National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)
Outcome measures
| Measure |
OTX-DP
n=22 Participants
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=21 Participants
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Total Conjunctival Lissamine Green Staining
|
6.41 units on a scale
Standard Deviation 2.130
|
7.81 units on a scale
Standard Deviation 3.642
|
Adverse Events
OTX-DP
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo Vehicle
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OTX-DP
n=22 participants at risk
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=21 participants at risk
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
Other adverse events
| Measure |
OTX-DP
n=22 participants at risk
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
|
Placebo Vehicle
n=21 participants at risk
PV (placebo drug delivery vehicle)
|
|---|---|---|
|
General disorders
Adverse Events
|
68.2%
15/22 • Number of events 24
|
52.4%
11/21 • Number of events 22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place