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

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ClinicalTrials.gov Identifier: NCT02062905
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : May 9, 2016
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Ocular Therapeutix, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: OTX-DP treatment Device: Placebo Plug with no drug Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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™)
Study Start Date : March 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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)



Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062905


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

Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT02062905     History of Changes
Other Study ID Numbers: OTX-14-001
First Posted: February 14, 2014    Key Record Dates
Results First Posted: May 9, 2016
Last Update Posted: February 6, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases