DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

DEXTENZA Versus Topical Steroid or Antihistamine Therapy for Treatment of Allergic Conjunctivitis

This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to compare patient-reported and clinical outcomes with DEXTENZA versus topical steroid or antihistamine treatment in patients with allergic conjunctivitis

Study Overview

• Status: Completed
• Conditions: Bilateral Conjunctivitis (Disorder)
• Intervention / Treatment: Drug: Dexamethasone ophthalmic insert 0.4Mg; Drug: olopatadine hydrochloride ophthalmic solution 0.7%; Drug: 0.2% loteprednol etabonate ophthalmic suspension

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be at least 18 years of age
• Provide written informed consent and sign HIPAA form
• Be willing and able to follow all instructions and attend all study visits
• Be able and willing to discontinue wearing contact lenses throughout the study period
• Have a BCVA of ≥50 ETDRS letters (20/100 Snellen equivalent or better) in each eye as measured at Screening visit
• Have urine pregnancy testing for women considered capable of becoming pregnant; not be lactating; and agree to use a medically acceptable form of birth control throughout the study period
• Have a positive history of bilateral ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen as confirmed by the allergy testing at the Screening visit

Exclusion Criteria:

• • Known contraindications or sensitivities to the use of any of the medications required per protocol, including known steroid responders

  • Have any ocular condition that in the opinion of the Investigator could affect the subject's safety or study parameters (including, but not limited to uncontrolled narrow angle glaucoma, severe blepharitis, follicular conjunctivitis, iritis, pterygium, dry eye diagnosis, or active ocular infection)
  • Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
  • Use of systemic, inhaled, or nasal steroids
  • Use of new systemic antihistamine use within 30 days of Screening visit
  • Use of ocular or topical non-steroidal anti-inflammatory drugs (NSAIDs)
  • Use of lid scrubs
  • Use of decongestants
  • Use of immunotherapeutic agents
  • Use of monoamine oxidase inhibitors (MAOIs)
  • Have a congenital or ocular anomaly or anomaly of the punctum that may preclude placement of DEXTENZA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DEXTENZA; DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use	Drug: Dexamethasone ophthalmic insert 0.4Mg; Dextenza 0.4Mg Ophthalmic Insert; Other Names: Dextenza
ACTIVE_COMPARATOR: Antihistamine; PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% for topical ophthalmic administration.	Drug: olopatadine hydrochloride ophthalmic solution 0.7%; olopatadine hydrochloride ophthalmic solution 0.7%; Other Names: PAZEO
ACTIVE_COMPARATOR: Topical Steroid; ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use.	Drug: 0.2% loteprednol etabonate ophthalmic suspension; 0.2% loteprednol etabonate ophthalmic suspension; Other Names: ALREX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)	Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)	30 days

Collaborators and Investigators

• Sponsor: Clinical Research Center of Florida
• Collaborators: Ocular Therapeutix, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2021
• Primary Completion (ACTUAL): September 2, 2021
• Study Completion (ACTUAL): September 2, 2021

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (ACTUAL): January 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Pharmaceutical Solutions; Histamine H1 Antagonists, Non-Sedating; Dexamethasone; Loteprednol Etabonate; Ophthalmic Solutions; Olopatadine Hydrochloride
• Other Study ID Numbers: The Dex-AC Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No