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Phase 2/3 Study Evaluating Efficacy and Safety of OTX-DP for Treatment of Chronic Allergic Conjunctivitis

This study has been completed.
ORA, Inc.
Information provided by (Responsible Party):
Ocular Therapeutix, Inc. Identifier:
First received: February 11, 2014
Last updated: December 13, 2016
Last verified: December 2016
The purpose of this study is to evaluate the efficacy and safety of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis.

Condition Intervention Phase
Allergic Conjunctivitis
Drug: OTX-DP treatment
Device: Placebo Plug with no drug
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single Center, Randomized, Double-Masked, Vehicle Controlled Phase 2/3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC™)

Resource links provided by NLM:

Further study details as provided by Ocular Therapeutix, Inc.:

Primary Outcome Measures:
  • Ocular Itching [ Time Frame: 14 days post insertion ]
    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 [ Time Frame: 14 days post insertion ]
    Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness)

Enrollment: 68
Study Start Date: March 2014
Study Completion Date: November 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OTX-DP treatment
OTX-DP (sustained release dexamethasone, 0.4 mg)
Drug: OTX-DP treatment
Placebo Comparator: Placebo Plug Delivery Vehicle
Placebo Plug with no drug
Device: Placebo Plug with no drug


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • be at least 18 years of age of either sex and any race
  • have a positive history of ocular allergies and a positive skin test reaction to a perennial allergen
  • have a calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart

Exclusion Criteria:

  • have known contraindications or sensitivities to the use of any of the investigational product medication or components
  • have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 3 months
  Contacts and Locations
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Please refer to this study by its identifier: NCT02062905

United States, Massachusetts
Ora, Inc.
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Ocular Therapeutix, Inc.
ORA, Inc.
  More Information

Responsible Party: Ocular Therapeutix, Inc. Identifier: NCT02062905     History of Changes
Other Study ID Numbers: OTX-14-001
Study First Received: February 11, 2014
Results First Received: February 29, 2016
Last Updated: December 13, 2016

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases processed this record on May 25, 2017