OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye
A Prospective, Multicenter, Randomized, Parallel-Arm, Bilateral, Double-Masked, Vehicle Controlled Feasibility Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye
1 other identifier
interventional
43
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 dry eye disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2015
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 4, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
March 29, 2018
CompletedMarch 29, 2018
March 1, 2018
7 months
June 4, 2015
October 30, 2017
March 2, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Total Corneal Fluorescein Staining
National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)
Day 15
Total Corneal Fluorescein Staining
National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)
Day 30
Total Conjunctival Lissamine Green Staining
National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)
Day 15
Total Conjunctival Lissamine Green Staining
National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)
Day 30
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:
- Had a known history of dry eye disease
- Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye
You may not qualify if:
- History of intraocular inflammation in either eye
- Use of the anti-inflammatory or immunomodulating agents ocular or systemic for the duration of the study
- Uncontrolled glaucoma or is on medications to treat glaucoma
- History of IOP spikes in either eye
- Active epiphora
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ocular Therapeutix, Inc.lead
- ORA, Inc.collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2015
First Posted
June 11, 2015
Study Start
January 1, 2015
Primary Completion
August 1, 2015
Study Completion
November 1, 2015
Last Updated
March 29, 2018
Results First Posted
March 29, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share