Trial Outcomes & Findings for OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery (NCT NCT02736175)

NCT ID: NCT02736175

Last Updated: 2017-11-13

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: 438 participants
• Primary outcome timeframe: Day 14
• Results posted on: 2017-11-13

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	216	222
Overall Study COMPLETED	214	221
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OTX-15:003: 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 n=216 Participants OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use	Placebo Vehicle n=222 Participants PV (placebo drug delivery vehicle)	Total n=438 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 9.09 • n=5 Participants	68.6 years STANDARD_DEVIATION 8.37 • n=7 Participants	68.0 years STANDARD_DEVIATION 8.75 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants	130 Participants n=7 Participants	250 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants	92 Participants n=7 Participants	188 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	179 Participants n=5 Participants	185 Participants n=7 Participants	364 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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) White	174 Participants n=5 Participants	189 Participants n=7 Participants	363 Participants n=5 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Iris Color Brown	106 Participants n=5 Participants	101 Participants n=7 Participants	207 Participants n=5 Participants
Iris Color Blue	61 Participants n=5 Participants	64 Participants n=7 Participants	125 Participants n=5 Participants
Iris Color Hazel	32 Participants n=5 Participants	37 Participants n=7 Participants	69 Participants n=5 Participants
Iris Color Green	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Iris Color Gray	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Iris Color Black	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14

Population: ITT LOCF (last observation carried forward)

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=216 Participants OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use	Placebo Vehicle n=222 Participants PV (placebo drug delivery vehicle)
Absence of Anterior Chamber Inflammation	52.3 percentage of total participants	31.1 percentage of total participants

PRIMARY outcome

Timeframe: Day 8

Population: ITT LOCF (last observation carried forward)

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

Outcome measures

Measure	OTX-DP n=216 Participants OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use	Placebo Vehicle n=222 Participants PV (placebo drug delivery vehicle)
Absence of Ocular Pain	79.6 percentage of total participants	61.3 percentage of total participants

Adverse Events

OTX-DP

Serious events: 3 serious events

Other events: 63 other events

Deaths: 0 deaths

Placebo Vehicle

Serious events: 2 serious events

Other events: 86 other events

Deaths: 0 deaths

Serious adverse events

Measure	OTX-DP n=216 participants at risk OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use	Placebo Vehicle n=221 participants at risk PV (placebo drug delivery vehicle)
Eye disorders Retinal detachment	0.46% 1/216	0.00% 0/221
Cardiac disorders Cardiac failure acute	0.46% 1/216	0.00% 0/221
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.46% 1/216	0.00% 0/221
Renal and urinary disorders Nephrolithiasis	0.00% 0/216	0.45% 1/221
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/216	0.45% 1/221

Other adverse events

Measure	OTX-DP n=216 participants at risk OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use	Placebo Vehicle n=221 participants at risk PV (placebo drug delivery vehicle)
General disorders Adverse Events	29.2% 63/216 • Number of events 91	38.9% 86/221 • Number of events 109

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