• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What are Clinical Trials?
    • Become a Clinical Trial Volunteer
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Ocular Therapeutix begins enrollment in phase III trial for allergic conjunctivitis

Ocular Therapeutix begins enrollment in phase III trial for allergic conjunctivitis

June 17, 2015
CenterWatch Staff

Ocular Therapeutix, a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, has enrolled its first patients in a phase III clinical trial to evaluate the safety and efficacy of Dextenza (sustained release dexamethasone, 0.4mg) for the treatment of allergic conjunctivitis. Dextenza is administered by a physician as a bioresorbable intracanalicular depot for drug release to the ocular surface for up 30 days.

This prospective, U.S.-based, multicenter, 1:1 randomized, parallel-arm, double-masked, vehicle-controlled study is enrolling subjects who exhibit chronic signs and symptoms of allergic conjunctivitis. This is the first of two phase III studies and will evaluate Dextenza versus a placebo vehicle punctum plug using Ora’s modified Conjunctival Allergen Challenge (Ora-CAC) Model (Ora, Andover, Mass.), which accommodates for the longer therapeutic effect of a one-time administered sustained release drug product.

The study is designed to assess the effect of Dextenza compared with placebo on allergic reactions using three series of successive allergen challenges over a 30-day period. Dextenza or placebo will be administered 48 to 72 hours after final confirmatory exposure to the allergen, and the primary endpoints to be evaluated are ocular itching and conjunctival redness at day seven following insertion. The secondary efficacy measures for both itching and redness are measured at day 14 following insertion and on days 27-30 post-insertion.

Allergic conjunctivitis is an inflammatory disease of the conjunctiva resulting primarily from a reaction to allergy-causing substances such as pollen or pet dander. The primary sign of this inflammation is conjunctival redness and the primary symptom is acute ocular itching. Allergic conjunctivitis ranges in clinical severity from relatively mild, common forms to more severe forms that can cause impaired vision. 

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Jonathan Seltzer

      Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials

    • Quality_Compass-360x240.png

      Ask the Experts: Applying Quality by Design to Protocols

    • Obesity Treatment Patient

      Clinical Trials Need Greater Representation of Obese Patients, Experts Say

    • Modernize-360x240.png

      FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing