DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

Phase 4

Completed

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

• Registration Number: NCT04708821
• Lead Sponsor: Clinical Research Center of Florida

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Study Start: 2021-04-30
• Primary Completion: 2021-09-02
• Study Completion: 2021-09-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEXTENZA	Dexamethasone ophthalmic insert 0.4Mg	DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use
Topical Steroid	0.2% loteprednol etabonate ophthalmic suspension	ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use.
Antihistamine	olopatadine hydrochloride ophthalmic solution 0.7%	PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% for topical ophthalmic administration.

Primary Outcome Measures

Name	Time	Method
Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)	30 days	Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)

Trial Locations

Locations (1)

Clinical Research Center of Florida; 🇺🇸 Pompano Beach, Florida, United States