DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

NCT ID: NCT04708821

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2021-09-02

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DEXTENZA

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

Group Type: EXPERIMENTAL

Dexamethasone ophthalmic insert 0.4Mg

Intervention Type: DRUG

Dextenza 0.4Mg Ophthalmic Insert

Antihistamine

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

Group Type: ACTIVE_COMPARATOR

olopatadine hydrochloride ophthalmic solution 0.7%

Intervention Type: DRUG

olopatadine hydrochloride ophthalmic solution 0.7%

Topical Steroid

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

Group Type: ACTIVE_COMPARATOR

0.2% loteprednol etabonate ophthalmic suspension

Intervention Type: DRUG

0.2% loteprednol etabonate ophthalmic suspension

Interventions

Dexamethasone ophthalmic insert 0.4Mg

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type: DRUG

0.2% loteprednol etabonate ophthalmic suspension

0.2% loteprednol etabonate ophthalmic suspension

Intervention Type: DRUG

olopatadine hydrochloride ophthalmic solution 0.7%

olopatadine hydrochloride ophthalmic solution 0.7%

Intervention Type: DRUG

Other Intervention Names

Dextenza; ALREX; PAZEO

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role: collaborator

Clinical Research Center of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Research Center of Florida

Pompano Beach, Florida, United States

Countries

United States

Other Identifiers

The Dex-AC Study

Identifier Type: -

Identifier Source: org_study_id