DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

Bilateral Conjunctivitis (Disorder) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04708821
• Other study ID #: The Dex-AC Study
• Status: Completed
• Phase: Phase 4
• Start date: April 30, 2021
• Est. completion date: September 2, 2021

Study information

• Verified date: April 2022
• Source: Clinical Research Center of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bilateral Conjunctivitis (Disorder)
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Dexamethasone ophthalmic insert 0.4Mg
Dextenza 0.4Mg Ophthalmic Insert
• 0.2% loteprednol etabonate ophthalmic suspension
0.2% loteprednol etabonate ophthalmic suspension
• olopatadine hydrochloride ophthalmic solution 0.7%
olopatadine hydrochloride ophthalmic solution 0.7%

Locations

Country	Name	City	State
United States	Clinical Research Center of Florida	Pompano Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Research Center of Florida	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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