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OpenTrials
Completed

NCT Number: NCT04708821

DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone ophthalmic insert 0.4Mg

Drug

Dextenza 0.4Mg Ophthalmic Insert

Other names: Dextenza

0.2% loteprednol etabonate ophthalmic suspension

Drug

0.2% loteprednol etabonate ophthalmic suspension

Other names: ALREX

olopatadine hydrochloride ophthalmic solution 0.7%

Drug

olopatadine hydrochloride ophthalmic solution 0.7%

Other names: PAZEO

Primary outcomes

  1. Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)

    Time frame: 30 days

    Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)

Sponsors and collaborators

Lead sponsor

Clinical Research Center of Florida

Other

Collaborators

  • Ocular Therapeutix, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2021
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.