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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier:
NCT02062905
First received: February 11, 2014
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Conjunctival redness [ Time Frame: 14 days post insertion ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Distance visual acuity [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    A worsening of acuity of 10 letters or greater from the previous study visit


Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062905

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

No publications provided

Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT02062905     History of Changes
Other Study ID Numbers: OTX-14-001
Study First Received: February 11, 2014
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014