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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02034019
Enrollment
247
Registered
2014-01-13
Start date
2014-02-28
Completion date
2015-02-28
Last updated
2020-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Ocular Surgical Inflammation and Pain

Brief summary

To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

Interventions

DRUGDexamethasone
DRUGPunctum Plug

Sponsors

Ocular Therapeutix, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens * Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

Exclusion criteria

* Any intraocular inflammation in the study eye present during the screening slit lamp examination * Score greater than 0 on the Ocular Pain Assessment in the study eye at Screening * Any intraocular inflammation in the study eye present during the screening slit lamp examination

Design outcomes

Primary

MeasureTime frame
Absence of Cells in Anterior Chamber of the Study EyeDay 14
Absence of Pain in Study EyeDay 8

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
OTX-DP (Dexamethasone Punctum Plug)
Resorbable hydrogel drug delivery vehicle containing dexamethasone Dexamethasone Punctum Plug
164
PVPP (Placebo Punctum Plug)
Resorbable hydrogel drug delivery vehicle containing no drug Punctum Plug
83
Total247

Baseline characteristics

CharacteristicOTX-DP (Dexamethasone Punctum Plug)PVPP (Placebo Punctum Plug)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
108 Participants67 Participants175 Participants
Age, Categorical
Between 18 and 65 years
56 Participants16 Participants72 Participants
Sex: Female, Male
Female
103 Participants44 Participants147 Participants
Sex: Female, Male
Male
61 Participants39 Participants100 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
37 / 16231 / 84
serious
Total, serious adverse events
0 / 1621 / 84

Outcome results

Primary

Absence of Cells in Anterior Chamber of the Study Eye

Time frame: Day 14

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OTX-DP (Dexamethasone Punctum Plug)Absence of Cells in Anterior Chamber of the Study Eye54 Participants
PVPP (Placebo Punctum Plug)Absence of Cells in Anterior Chamber of the Study Eye12 Participants
Primary

Absence of Pain in Study Eye

Time frame: Day 8

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OTX-DP (Dexamethasone Punctum Plug)Absence of Pain in Study Eye131 Participants
PVPP (Placebo Punctum Plug)Absence of Pain in Study Eye36 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026