Trial Outcomes & Findings for OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis (NCT NCT02062905)
NCT ID: NCT02062905
Last Updated: 2019-09-11
Results Overview
Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
14 days post insertion
Results posted on
2019-09-11
Participant Flow
Participant milestones
| Measure |
OTX-DP Treatment
OTX-DP (sustained release dexamethasone, 0.4 mg)
OTX-DP treatment
|
Placebo Plug Delivery Vehicle
Placebo Plug with no drug
Placebo Plug with no drug
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
33
|
|
Overall Study
COMPLETED
|
28
|
31
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
OTX-DP Treatment
n=35 Participants
OTX-DP (sustained release dexamethasone, 0.4 mg)
OTX-DP treatment
|
Placebo Plug Delivery Vehicle
n=33 Participants
Placebo Plug with no drug
Placebo Plug with no drug
|
Total
n=68 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
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 days post insertionProprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)
Outcome measures
| Measure |
OTX-DP Treatment
n=28 Participants
OTX-DP (sustained release dexamethasone, 0.4 mg)
OTX-DP treatment
|
Placebo Plug Delivery Vehicle
n=31 Participants
Placebo Plug with no drug
Placebo Plug with no drug
|
|---|---|---|
|
Ocular Itching
3 min (14 days post-insertion)
|
1.80 units on a scale (0 -4)
Standard Deviation 1.068
|
2.58 units on a scale (0 -4)
Standard Deviation 0.823
|
|
Ocular Itching
5 min. (14 days post-insertion)
|
1.72 units on a scale (0 -4)
Standard Deviation 0.998
|
2.70 units on a scale (0 -4)
Standard Deviation 0.865
|
|
Ocular Itching
7 min. (14 days post-insertion)
|
1.65 units on a scale (0 -4)
Standard Deviation 0.989
|
2.53 units on a scale (0 -4)
Standard Deviation 0.880
|
SECONDARY outcome
Timeframe: 14 days post insertionProprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness)
Outcome measures
| Measure |
OTX-DP Treatment
n=28 Participants
OTX-DP (sustained release dexamethasone, 0.4 mg)
OTX-DP treatment
|
Placebo Plug Delivery Vehicle
n=31 Participants
Placebo Plug with no drug
Placebo Plug with no drug
|
|---|---|---|
|
Conjunctival Redness
7 min. (14 days post-insertion)
|
1.60 units on a scale (0 - 4)
Standard Deviation 0.753
|
2.11 units on a scale (0 - 4)
Standard Deviation 0.727
|
|
Conjunctival Redness
15 min. (14 days post-insertion)
|
1.53 units on a scale (0 - 4)
Standard Deviation 0.753
|
2.23 units on a scale (0 - 4)
Standard Deviation 0.708
|
|
Conjunctival Redness
20 min. (14 days post-insertion)
|
1.54 units on a scale (0 - 4)
Standard Deviation 0.739
|
2.21 units on a scale (0 - 4)
Standard Deviation 0.696
|
Adverse Events
OTX-DP Treatment
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Plug Delivery Vehicle
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OTX-DP Treatment
n=31 participants at risk
OTX-DP (sustained release dexamethasone, 0.4 mg)
OTX-DP treatment
|
Placebo Plug Delivery Vehicle
n=33 participants at risk
Placebo Plug with no drug
Placebo Plug with no drug
|
|---|---|---|
|
Psychiatric disorders
depression
|
3.2%
1/31 • Number of events 1
|
0.00%
0/33
|
Other adverse events
| Measure |
OTX-DP Treatment
n=31 participants at risk
OTX-DP (sustained release dexamethasone, 0.4 mg)
OTX-DP treatment
|
Placebo Plug Delivery Vehicle
n=33 participants at risk
Placebo Plug with no drug
Placebo Plug with no drug
|
|---|---|---|
|
Eye disorders
eye discharge
|
3.2%
1/31 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER