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DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

Primary Purpose

Bilateral Conjunctivitis (Disorder)

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone ophthalmic insert 0.4Mg
0.2% loteprednol etabonate ophthalmic suspension
olopatadine hydrochloride ophthalmic solution 0.7%
Sponsored by
Clinical Research Center of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilateral Conjunctivitis (Disorder)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Research Center of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

DEXTENZA

Antihistamine

Topical Steroid

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
December 15, 2020
Last Updated
April 6, 2022
Sponsor
Clinical Research Center of Florida
Collaborators
Ocular Therapeutix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04708821
Brief Title
DEXTENZA Therapy for Treatment of Allergic Conjunctivitis
Official Title
DEXTENZA Versus Topical Steroid or Antihistamine Therapy for Treatment of Allergic Conjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
September 2, 2021 (Actual)
Study Completion Date
September 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Research Center of Florida
Collaborators
Ocular Therapeutix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Conjunctivitis (Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEXTENZA
Arm Type
Experimental
Arm Description
DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use
Arm Title
Antihistamine
Arm Type
Active Comparator
Arm Description
PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% for topical ophthalmic administration.
Arm Title
Topical Steroid
Arm Type
Active Comparator
Arm Description
ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone ophthalmic insert 0.4Mg
Other Intervention Name(s)
Dextenza
Intervention Description
Dextenza 0.4Mg Ophthalmic Insert
Intervention Type
Drug
Intervention Name(s)
0.2% loteprednol etabonate ophthalmic suspension
Other Intervention Name(s)
ALREX
Intervention Description
0.2% loteprednol etabonate ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
olopatadine hydrochloride ophthalmic solution 0.7%
Other Intervention Name(s)
PAZEO
Intervention Description
olopatadine hydrochloride ophthalmic solution 0.7%
Primary Outcome Measure Information:
Title
Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)
Description
Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Clinical Research Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States

12. IPD Sharing Statement

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DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

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