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OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

Primary Purpose

Chronic Allergic Conjunctivitis

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 Chronic Allergic Conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of ocular surgical intervention within the past 3 months
  • Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
  • Use any of the following disallowed medications during the period indicated

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

    Ocular Itching
    Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)

    Secondary Outcome Measures

    Conjunctival Redness
    Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness)

    Full Information

    First Posted
    February 11, 2014
    Last Updated
    August 28, 2019
    Sponsor
    Ocular Therapeutix, Inc.
    Collaborators
    ORA, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02062905
    Brief Title
    OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
    Official Title
    A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 2 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC™)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    November 2014 (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 chronic allergic conjunctivitis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Allergic Conjunctivitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    68 (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
    Ocular Itching
    Description
    Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)
    Time Frame
    14 days post insertion
    Secondary Outcome Measure Information:
    Title
    Conjunctival Redness
    Description
    Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness)
    Time Frame
    14 days post insertion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: History of ocular surgical intervention within the past 3 months Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit Use any of the following disallowed medications during the period indicated

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

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