OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3B Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
1 other identifier
interventional
241
0 countries
N/A
Brief Summary
The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular 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 Apr 2014
Shorter than P25 for phase_3
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
March 13, 2014
CompletedFirst Posted
Study publicly available on registry
March 17, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
March 30, 2016
CompletedSeptember 26, 2019
September 1, 2019
9 months
March 13, 2014
February 29, 2016
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With an Absence of Anterior Chamber Inflammation
Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14
Day 14
Number of Participants With an Absence of Ocular Pain
Absence of pain (i.e., score of '0') in the study eye at Day 8
Day 8
Study Arms (2)
OTX-DP
EXPERIMENTALOTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
PV
PLACEBO COMPARATORPV (placebo drug delivery vehicle)
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 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jamie L. Metzinger, Medical Affairs
- Organization
- Ocular Therapeutix
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
March 13, 2014
First Posted
March 17, 2014
Study Start
April 1, 2014
Primary Completion
January 1, 2015
Study Completion
March 1, 2015
Last Updated
September 26, 2019
Results First Posted
March 30, 2016
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share