OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)
1 other identifier
interventional
86
0 countries
N/A
Brief Summary
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2015
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
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2016
CompletedFirst Submitted
Initial submission to the registry
December 2, 2016
CompletedFirst Posted
Study publicly available on registry
December 9, 2016
CompletedResults Posted
Study results publicly available
April 30, 2018
CompletedOctober 12, 2020
March 1, 2018
11 months
December 2, 2016
November 15, 2017
September 14, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
3 minutes
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
5 minutes
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
7 minutes
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 positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
- Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation
You may not qualify if:
- History of refractive surgery (including LASIK procedures) within the past 2 years
- History of retinal detachment, diabetic retinopathy, or active retinal disease
- Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
- Use any of the disallowed medications during the period indicated
- History of IOP increase as a result of steroid treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ocular Therapeutix, Inc.lead
- ORA, Inc.collaborator
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
December 2, 2016
First Posted
December 9, 2016
Study Start
June 1, 2015
Primary Completion
April 27, 2016
Study Completion
April 27, 2016
Last Updated
October 12, 2020
Results First Posted
April 30, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share