Trial Outcomes & Findings for OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery (NCT NCT02089113)

NCT ID: NCT02089113

Last Updated: 2019-09-26

Results Overview

Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 241 participants
• Primary outcome timeframe: Day 14
• Results posted on: 2019-09-26

Participant Flow

Participant milestones

Measure	Dexamethasone Punctum Plug Drug treatment	Placebo Vehicle Punctum Plug No drug treatment
Overall Study STARTED	161	80
Overall Study COMPLETED	160	80
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Baseline characteristics by cohort

Measure	OTX-DP (Dexamethasone Punctum Plug) n=161 Participants Resorbable hydrogel drug delivery vehicle containing dexamethasone Dexamethasone	PVPP (Placebo Punctum Plug) n=80 Participants Resorbable hydrogel drug delivery vehicle containing no drug Punctum Plug	Total n=241 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	49 Participants n=5 Participants	22 Participants n=7 Participants	71 Participants n=5 Participants
Age, Categorical >=65 years	112 Participants n=5 Participants	58 Participants n=7 Participants	170 Participants n=5 Participants
Sex: Female, Male Female	98 Participants n=5 Participants	39 Participants n=7 Participants	137 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	41 Participants n=7 Participants	104 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14

Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14

Outcome measures

Measure	OTX-DP n=161 Participants OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use	Placebo Vehicle n=80 Participants PV (placebo drug delivery vehicle)
Number of Participants With an Absence of Anterior Chamber Inflammation	63 participants	25 participants

PRIMARY outcome

Timeframe: Day 8

Absence of pain (i.e., score of '0') in the study eye at Day 8

Outcome measures

Measure	OTX-DP n=161 Participants OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use	Placebo Vehicle n=80 Participants PV (placebo drug delivery vehicle)
Number of Participants With an Absence of Ocular Pain	124 participants	47 participants

Adverse Events

Dexamethasone Punctum Plug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Vehicle Punctum Plug

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexamethasone Punctum Plug n=160 participants at risk Drug treatment	Placebo Vehicle Punctum Plug n=80 participants at risk No drug treatment
Psychiatric disorders mental disorder	0.00% 0/160	1.2% 1/80 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Jamie L. Metzinger, Medical Affairs

Ocular Therapeutix

Phone: 781-357-4000

Email: jmetzinger@ocutx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place