DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

Sponsor

Clinical Research Center of Florida (Other)

Overall Status

Completed

CT.gov ID

NCT04708821

Collaborator

Ocular Therapeutix, Inc. (Industry)

Enrollment

Location

Arms

4.1

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Bilateral Conjunctivitis (Disorder)	Drug: Dexamethasone ophthalmic insert 0.4Mg Drug: 0.2% loteprednol etabonate ophthalmic suspension Drug: olopatadine hydrochloride ophthalmic solution 0.7%	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 30, 2021

Actual Primary Completion Date :

Sep 2, 2021

Actual Study Completion Date :

Sep 2, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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