Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
1 other identifier
interventional
247
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
January 31, 2020
CompletedJanuary 31, 2020
January 1, 2020
10 months
January 9, 2014
February 29, 2016
January 22, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Absence of Cells in Anterior Chamber of the Study Eye
Day 14
Absence of Pain in Study Eye
Day 8
Study Arms (2)
OTX-DP (Dexamethasone Punctum Plug)
ACTIVE COMPARATORResorbable hydrogel drug delivery vehicle containing dexamethasone
PVPP (Placebo Punctum Plug)
PLACEBO COMPARATORResorbable hydrogel drug delivery vehicle containing no drug
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texan Eye / Keystone Research, Ltd.
Austin, Texas, 78731, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Affairs
- Organization
- Ocular Therapeutix, Inc.
Study Officials
- STUDY DIRECTOR
Clinical Project Manager
Ocular Therapeutix
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2014
First Posted
January 13, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2014
Study Completion
February 1, 2015
Last Updated
January 31, 2020
Results First Posted
January 31, 2020
Record last verified: 2020-01