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OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Primary Purpose

Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation

Status
Completed
Phase
Phase 3
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 Post-Surgical Ocular Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber lens
  • Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

Exclusion Criteria:

  • Any intraocular inflammation in the study eye present during the screening slit lamp examination
  • Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
  • Any intraocular inflammation in the study eye present during the screening slit lamp examination

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

    Number of Participants With an Absence of Anterior Chamber Inflammation
    Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14
    Number of Participants With an Absence of Ocular Pain
    Absence of pain (i.e., score of '0') in the study eye at Day 8

    Secondary Outcome Measures

    Full Information

    First Posted
    March 13, 2014
    Last Updated
    September 10, 2019
    Sponsor
    Ocular Therapeutix, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02089113
    Brief Title
    OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
    Official Title
    A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3B Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (Actual)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    241 (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
    Procedure
    Intervention Name(s)
    Placebo Vehicle
    Primary Outcome Measure Information:
    Title
    Number of Participants With an Absence of Anterior Chamber Inflammation
    Description
    Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14
    Time Frame
    Day 14
    Title
    Number of Participants With an Absence of Ocular Pain
    Description
    Absence of pain (i.e., score of '0') in the study eye at Day 8
    Time Frame
    Day 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber lens Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes Exclusion Criteria: Any intraocular inflammation in the study eye present during the screening slit lamp examination Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening Any intraocular inflammation in the study eye present during the screening slit lamp examination

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

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