DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

Clinical Research Center of Florida

Status and phase: Completed; Phase 4

Conditions: Bilateral Conjunctivitis (Disorder)

Treatments: Drug: olopatadine hydrochloride ophthalmic solution 0.7%; Drug: Dexamethasone ophthalmic insert 0.4Mg; Drug: 0.2% loteprednol etabonate ophthalmic suspension

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04708821

The Dex-AC Study

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 3 patient groups

DEXTENZA

Experimental group

Description:

DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use

Treatment:

Drug: Dexamethasone ophthalmic insert 0.4Mg

Antihistamine

Active Comparator group

Description:

PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% for topical ophthalmic administration.

Treatment:

Drug: olopatadine hydrochloride ophthalmic solution 0.7%

Topical Steroid

Active Comparator group

Description:

ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use.

Treatment:

Drug: 0.2% loteprednol etabonate ophthalmic suspension