Trial Outcomes & Findings for Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery (NCT NCT02034019)

NCT ID: NCT02034019

Last Updated: 2020-01-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 247 participants
• Primary outcome timeframe: Day 14
• Results posted on: 2020-01-31

Participant Flow

One subject inadvertently received PVPP instead of OTX-DP, as they had been randomized. This subject was followed safety but not included in the PP analysis.

Participant milestones

Measure	OTX-DP (Dexamethasone Punctum Plug) Resorbable hydrogel drug delivery vehicle containing dexamethasone Dexamethasone Punctum Plug	PVPP (Placebo Punctum Plug) Resorbable hydrogel drug delivery vehicle containing no drug Punctum Plug
Overall Study STARTED	164	83
Overall Study COMPLETED	163	81
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

Baseline characteristics by cohort

Measure	OTX-DP (Dexamethasone Punctum Plug) n=164 Participants Resorbable hydrogel drug delivery vehicle containing dexamethasone Dexamethasone Punctum Plug	PVPP (Placebo Punctum Plug) n=83 Participants Resorbable hydrogel drug delivery vehicle containing no drug Punctum Plug	Total n=247 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	56 Participants n=5 Participants	16 Participants n=7 Participants	72 Participants n=5 Participants
Age, Categorical >=65 years	108 Participants n=5 Participants	67 Participants n=7 Participants	175 Participants n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	44 Participants n=7 Participants	147 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	39 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14

Outcome measures

Measure	OTX-DP (Dexamethasone Punctum Plug) n=164 Participants Resorbable hydrogel drug delivery vehicle containing dexamethasone Dexamethasone Punctum Plug	PVPP (Placebo Punctum Plug) n=83 Participants Resorbable hydrogel drug delivery vehicle containing no drug Punctum Plug
Absence of Cells in Anterior Chamber of the Study Eye	54 Participants	12 Participants

PRIMARY outcome

Timeframe: Day 8

Outcome measures

Measure	OTX-DP (Dexamethasone Punctum Plug) n=164 Participants Resorbable hydrogel drug delivery vehicle containing dexamethasone Dexamethasone Punctum Plug	PVPP (Placebo Punctum Plug) n=83 Participants Resorbable hydrogel drug delivery vehicle containing no drug Punctum Plug
Absence of Pain in Study Eye	131 Participants	36 Participants

Adverse Events

OTX-DP (Dexamethasone Punctum Plug)

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

PVPP (Placebo Punctum Plug)

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	OTX-DP (Dexamethasone Punctum Plug) n=162 participants at risk Resorbable hydrogel drug delivery vehicle containing dexamethasone Dexamethasone Punctum Plug	PVPP (Placebo Punctum Plug) n=84 participants at risk Resorbable hydrogel drug delivery vehicle containing no drug Punctum Plug
Eye disorders hypopyon	0.00% 0/162 One subject was inadvertently treated with PVPP instead of OTX-TP, as they had been randomized. This subject was not included in the PP, but was followed for safety.	1.2% 1/84 • Number of events 1 One subject was inadvertently treated with PVPP instead of OTX-TP, as they had been randomized. This subject was not included in the PP, but was followed for safety.

Other adverse events

Measure	OTX-DP (Dexamethasone Punctum Plug) n=162 participants at risk Resorbable hydrogel drug delivery vehicle containing dexamethasone Dexamethasone Punctum Plug	PVPP (Placebo Punctum Plug) n=84 participants at risk Resorbable hydrogel drug delivery vehicle containing no drug Punctum Plug
Eye disorders inflammation	22.8% 37/162 • Number of events 47 One subject was inadvertently treated with PVPP instead of OTX-TP, as they had been randomized. This subject was not included in the PP, but was followed for safety.	36.9% 31/84 • Number of events 38 One subject was inadvertently treated with PVPP instead of OTX-TP, as they had been randomized. This subject was not included in the PP, but was followed for safety.

Additional Information

Director, Clinical Affairs

Ocular Therapeutix, Inc.

Phone: 781-357-4000

Email: dmulani@ocutx.com

Results disclosure agreements

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

Restriction type: OTHER