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A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of 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: NCT04050865
Recruitment Status : Completed
First Posted : August 8, 2019
Results First Posted : October 7, 2021
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
Ocular Therapeutix, Inc.

Brief Summary:
The objective of the study is to evaluate the efficacy and safety of OTX-DP as a dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of allergic conjunctivitis.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Dexamethasone, 0.4mg Device: Placebo plug with no drug Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CLN-0052, A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluation the Efficacy and Safety of OTX-DP for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (Ora-CAC®)
Actual Study Start Date : August 5, 2019
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: OTX-DP Drug: Dexamethasone, 0.4mg
Ophthalmic Insert
Other Name: OTX-DP

Placebo Comparator: Placebo Device: Placebo plug with no drug
Ophthalmic Insert




Primary Outcome Measures :
  1. Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion) [ Time Frame: 3 minutes ]
    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit Increments; 0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed

  2. Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion) [ Time Frame: 5 minutes ]

    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments;

    0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed


  3. Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion) [ Time Frame: 7 minutes ]

    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments;

    0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) within the past 2 years
  • 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
  • History of IOP increase as a result of steroid treatment
  • A female who is currently pregnant, planning a pregnancy, or lactating

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): NCT04050865


Locations
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United States, Colorado
Vision Institute
Colorado Springs, Colorado, United States, 80907
United States, Kentucky
The Eye Care Institute
Louisville, Kentucky, United States, 40206
United States, Massachusetts
Andover Eye Associates
Raynham, Massachusetts, United States, 02767
United States, Missouri
Silverstein Eye Centers
Kansas City, Missouri, United States, 64133
United States, Tennessee
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119
United States, Texas
Eye Associates of Texas
Round Rock, Texas, United States, 78681
Sponsors and Collaborators
Ocular Therapeutix, Inc.
  Study Documents (Full-Text)

Documents provided by Ocular Therapeutix, Inc.:
Study Protocol  [PDF] October 29, 2019
Statistical Analysis Plan  [PDF] March 27, 2020

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Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT04050865    
Other Study ID Numbers: CLN-Protocol-0052
First Posted: August 8, 2019    Key Record Dates
Results First Posted: October 7, 2021
Last Update Posted: October 7, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: 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