Trial Outcomes & Findings for Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery (NCT NCT01666210)

NCT ID: NCT01666210

Last Updated: 2021-10-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: Day 8
• Results posted on: 2021-10-19

Participant Flow

Participant milestones

Measure	Dexamethasone Punctum Plug Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug	Placebo Vehicle Punctum Plug Placebo punctum plug insertion Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone
Overall Study STARTED	30	30
Overall Study COMPLETED	28	29
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Dexamethasone Punctum Plug n=30 Participants Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug	Placebo Vehicle Punctum Plug n=30 Participants Placebo punctum plug insertion Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone	Total n=60 Participants Total of all reporting groups
Age, Customized Age between 21 - 65	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Age, Customized Age greater than or equal to 65	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 8

Outcome measures

Measure	Dexamethasone Punctum Plug n=30 Participants Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug	Placebo Vehicle Punctum Plug n=30 Participants Placebo punctum plug insertion Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone
Absence of Cells in Anterior Chamber of Study Eye	6 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 8

Outcome measures

Measure	Dexamethasone Punctum Plug n=29 Participants Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug	Placebo Vehicle Punctum Plug n=30 Participants Placebo punctum plug insertion Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone
Absence of Pain in the Study Eye	23 Participants	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of each individual subject's participation in the study, up to 60 days

Population: Ocular adverse events

Measure of adverse events over the duration of each subject's participation in the study.

Outcome measures

Measure	Dexamethasone Punctum Plug n=29 Participants Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug	Placebo Vehicle Punctum Plug n=30 Participants Placebo punctum plug insertion Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone
Adverse Events	4 Participants	7 Participants

Adverse Events

Dexamethasone Punctum Plug

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Vehicle Punctum Plug

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexamethasone Punctum Plug n=29 participants at risk Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug	Placebo Vehicle Punctum Plug n=30 participants at risk Placebo punctum plug insertion Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone
General disorders Syncope	0.00% 0/29 • The analyses of safety were based primarily on the incidence of treatment-emergent adverse events up to 60 days. The number of subjects in the OTX-DP group is confirmed as 29, one subject was not treated due to the inability to insert the plug in either eye.	3.3% 1/30 • The analyses of safety were based primarily on the incidence of treatment-emergent adverse events up to 60 days. The number of subjects in the OTX-DP group is confirmed as 29, one subject was not treated due to the inability to insert the plug in either eye.

Other adverse events

Measure	Dexamethasone Punctum Plug n=29 participants at risk Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug	Placebo Vehicle Punctum Plug n=30 participants at risk Placebo punctum plug insertion Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone
Eye disorders Eye disorders	10.3% 3/29 • Number of events 6 • The analyses of safety were based primarily on the incidence of treatment-emergent adverse events up to 60 days. The number of subjects in the OTX-DP group is confirmed as 29, one subject was not treated due to the inability to insert the plug in either eye.	33.3% 10/30 • Number of events 15 • The analyses of safety were based primarily on the incidence of treatment-emergent adverse events up to 60 days. The number of subjects in the OTX-DP group is confirmed as 29, one subject was not treated due to the inability to insert the plug in either eye.

Additional Information

Eric Ankerud

Ocular Therapeutix, Inc.

Phone: 781-357-4013

Email: eankerud@ocutx.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PIs agree that the first publication of the data and results of the Study shall be made in conjunction with the presentation of a joint, multi-center publication of the Study results, with the investigators from all appropriate sites contributing data, analyses, and comments.
• Publication restrictions are in place

Restriction type: OTHER