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OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dexamethasone
Placebo Vehicle
Sponsored by
Ocular Therapeutix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Had a known history of dry eye disease
  • Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    OTX-DP

    PV

    Arm Description

    OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use

    PV (placebo drug delivery vehicle)

    Outcomes

    Primary Outcome Measures

    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)
    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)
    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)
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    June 4, 2015
    Last Updated
    March 2, 2018
    Sponsor
    Ocular Therapeutix, Inc.
    Collaborators
    ORA, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02468700
    Brief Title
    OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ocular Therapeutix, Inc.
    Collaborators
    ORA, Inc.

    4. Oversight

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    OTX-DP
    Arm Type
    Experimental
    Arm Description
    OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
    Arm Title
    PV
    Arm Type
    Placebo Comparator
    Arm Description
    PV (placebo drug delivery vehicle)
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Type
    Other
    Intervention Name(s)
    Placebo Vehicle
    Primary Outcome Measure Information:
    Title
    Total Corneal Fluorescein Staining
    Description
    National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)
    Time Frame
    Day 15
    Title
    Total Corneal Fluorescein Staining
    Description
    National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)
    Time Frame
    Day 30
    Title
    Total Conjunctival Lissamine Green Staining
    Description
    National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)
    Time Frame
    Day 15
    Title
    Total Conjunctival Lissamine Green Staining
    Description
    National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)
    Time Frame
    Day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Had a known history of dry eye disease Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye

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