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OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02445326
Recruitment Status : Completed
First Posted : May 15, 2015
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Ocular Therapeutix, Inc.

Study Description
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Brief Summary:
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use 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
Chronic Allergic Conjunctivitis Drug: Dexamethasone Other: Placebo Vehicle Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 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®)
Actual Study Start Date : April 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pink Eye

Arms and Interventions
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Arm Intervention/treatment
Experimental: OTX-DP
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
 Drug: Dexamethasone
Placebo Comparator: PV
PV (placebo drug delivery vehicle)
 Other: Placebo Vehicle


Outcome Measures
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Primary Outcome Measures :
  1. Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 [ Time Frame: 3 minutes ]
    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  2. Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 [ Time Frame: 5 minutes ]
    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  3. Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 [ Time Frame: 7 minutes ]
    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  4. Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 [ Time Frame: 7 minutes ]
    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  5. Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 [ Time Frame: 15 minutes ]
    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  6. Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 [ Time Frame: 20 minutes ]
    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None


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

Inclusion Criteria:

  • Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
  • Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria:

  • History of refractive surgery (including LASIK procedures)
  • History of retinal detachment, diabetic retinopathy, or active retinal disease
  • Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
  • Use any of the disallowed medications during the period indicated
  • History of IOP increase as a result of steroid treatment
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT02445326    
Other Study ID Numbers: OTX-14-007
First Posted: May 15, 2015    Key Record Dates
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents