OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye
NCT ID: NCT02468700
Last Updated: 2018-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2015-01-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OTX-DP
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
Dexamethasone
PV
PV (placebo drug delivery vehicle)
Placebo Vehicle
Interventions
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Dexamethasone
Placebo Vehicle
Eligibility Criteria
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Inclusion Criteria
* Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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ORA, Inc.
INDUSTRY
Ocular Therapeutix, Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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OTX-14-006
Identifier Type: -
Identifier Source: org_study_id
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