Trial Outcomes & Findings for To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease (NCT NCT04747977)
NCT ID: NCT04747977
Last Updated: 2023-02-22
Results Overview
The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia \[evaluated by the central reading center (CRC)\] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15). Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
Change from baseline (Day 1) at Visit 4 (Day 15)
Results posted on
2023-02-22
Participant Flow
Participant milestones
| Measure |
OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert
Subjects in this arm received 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert
|
OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert
Subjects in this arm received 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert
|
Hydrogel Vehicle (HV) Intracanalicular Insert
Subjects in this arm received Hydrogel Vehicle (HV) Intracanalicular Insert
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
58
|
|
Overall Study
COMPLETED
|
54
|
56
|
55
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease
Baseline characteristics by cohort
| Measure |
OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert
n=55 Participants
Subjects in this arm received 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert
|
OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert
n=56 Participants
Subjects in this arm received 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert
|
Hydrogel Vehicle (HV) Intracanalicular Insert
n=55 Participants
Subjects in this arm received Hydrogel Vehicle (HV) Intracanalicular Insert
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
65.4 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
45 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
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 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
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
118 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
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline (Day 1) at Visit 4 (Day 15)Population: mITT population: CFB in Photographic Assessment of Bulbar Conjunctival Hyperemia in the Worst Zone (highest grading score at baseline among nasal, temporal, and frontal zones) of Study Eye at Day 15
The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia \[evaluated by the central reading center (CRC)\] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15). Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia.
Outcome measures
| Measure |
OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert
n=55 Participants
Subjects in this arm received 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert
|
OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert
n=56 Participants
Subjects in this arm received 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert
|
Hydrogel Vehicle (HV) Intracanalicular Insert
n=55 Participants
Subjects in this arm received Hydrogel Vehicle (HV) Intracanalicular Insert
|
|---|---|---|---|
|
Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).
|
-0.51 score on a scale
Interval -0.65 to -0.37
|
-0.43 score on a scale
Interval -0.57 to -0.3
|
-0.21 score on a scale
Interval -0.35 to -0.07
|
Adverse Events
OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Hydrogel Vehicle (HV) Intracanalicular Insert
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert
n=55 participants at risk
Subjects in this arm received 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert
|
OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert
n=56 participants at risk
Subjects in this arm received 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert
|
Hydrogel Vehicle (HV) Intracanalicular Insert
n=55 participants at risk
Subjects in this arm received Hydrogel Vehicle (HV) Intracanalicular Insert
|
|---|---|---|---|
|
Infections and infestations
Cellulitis/Worsening of Cellulitis
|
0.00%
0/55 • Through study completion, an average of 10 weeks.
This analysis includes the Modified Intent To Treat (mITT) analysis set which includes all subjects in the Intent To Treat (ITT) population who received IP (OTX-DED or HV) in the study eye.
|
0.00%
0/56 • Through study completion, an average of 10 weeks.
This analysis includes the Modified Intent To Treat (mITT) analysis set which includes all subjects in the Intent To Treat (ITT) population who received IP (OTX-DED or HV) in the study eye.
|
1.8%
1/55 • Through study completion, an average of 10 weeks.
This analysis includes the Modified Intent To Treat (mITT) analysis set which includes all subjects in the Intent To Treat (ITT) population who received IP (OTX-DED or HV) in the study eye.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/55 • Through study completion, an average of 10 weeks.
This analysis includes the Modified Intent To Treat (mITT) analysis set which includes all subjects in the Intent To Treat (ITT) population who received IP (OTX-DED or HV) in the study eye.
|
0.00%
0/56 • Through study completion, an average of 10 weeks.
This analysis includes the Modified Intent To Treat (mITT) analysis set which includes all subjects in the Intent To Treat (ITT) population who received IP (OTX-DED or HV) in the study eye.
|
1.8%
1/55 • Through study completion, an average of 10 weeks.
This analysis includes the Modified Intent To Treat (mITT) analysis set which includes all subjects in the Intent To Treat (ITT) population who received IP (OTX-DED or HV) in the study eye.
|
Other adverse events
| Measure |
OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert
n=55 participants at risk
Subjects in this arm received 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert
|
OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert
n=56 participants at risk
Subjects in this arm received 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert
|
Hydrogel Vehicle (HV) Intracanalicular Insert
n=55 participants at risk
Subjects in this arm received Hydrogel Vehicle (HV) Intracanalicular Insert
|
|---|---|---|---|
|
Eye disorders
Eye Disorders
|
9.1%
5/55 • Through study completion, an average of 10 weeks.
This analysis includes the Modified Intent To Treat (mITT) analysis set which includes all subjects in the Intent To Treat (ITT) population who received IP (OTX-DED or HV) in the study eye.
|
17.9%
10/56 • Through study completion, an average of 10 weeks.
This analysis includes the Modified Intent To Treat (mITT) analysis set which includes all subjects in the Intent To Treat (ITT) population who received IP (OTX-DED or HV) in the study eye.
|
10.9%
6/55 • Through study completion, an average of 10 weeks.
This analysis includes the Modified Intent To Treat (mITT) analysis set which includes all subjects in the Intent To Treat (ITT) population who received IP (OTX-DED or HV) in the study eye.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place