Bilateral Conjunctivitis (Disorder)
Conditions
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
Interventions
DRUGDexamethasone ophthalmic insert 0.4Mg
Dextenza 0.4Mg Ophthalmic Insert
DRUG0.2% loteprednol etabonate ophthalmic suspension
0.2% loteprednol etabonate ophthalmic suspension
olopatadine hydrochloride ophthalmic solution 0.7%
Sponsors
Ocular Therapeutix, Inc.
Clinical Research Center of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed