DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

NCT04708821 | Completed Phase 4 FDA Drug

• 1 other identifier: The Dex-AC Study
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Bilateral Conjunctivitis (Disorder)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

DEXTENZA

EXPERIMENTAL

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

Drug: Dexamethasone ophthalmic insert 0.4Mg

Antihistamine

ACTIVE COMPARATOR

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

Drug: olopatadine hydrochloride ophthalmic solution 0.7%

Topical Steroid

ACTIVE COMPARATOR

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

Drug: 0.2% loteprednol etabonate ophthalmic suspension

Interventions

Dexamethasone ophthalmic insert 0.4Mg DRUG

Dextenza 0.4Mg Ophthalmic Insert

Also known as: Dextenza

DEXTENZA

0.2% loteprednol etabonate ophthalmic suspension DRUG

0.2% loteprednol etabonate ophthalmic suspension

Also known as: ALREX

Topical Steroid

olopatadine hydrochloride ophthalmic solution 0.7% DRUG

olopatadine hydrochloride ophthalmic solution 0.7%

Also known as: PAZEO

Antihistamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Research Center of Florida: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

MeSH Terms

Interventions

Calcium Dobesilate; Loteprednol Etabonate

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: January 14, 2021
• Study Start: April 30, 2021
• Primary Completion: September 2, 2021
• Study Completion: September 2, 2021
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

US (1)