DEXTENZA Versus Topical Steroid or Antihistamine Therapy for Treatment of Allergic Conjunctivitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •• 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
研究组 & 干预措施
DEXTENZA
DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use
干预措施: Dexamethasone ophthalmic insert 0.4Mg (Drug)
Antihistamine
PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% for topical ophthalmic administration.
干预措施: olopatadine hydrochloride ophthalmic solution 0.7% (Drug)
Topical Steroid
ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use.
干预措施: 0.2% loteprednol etabonate ophthalmic suspension (Drug)
结局指标
主要结局
Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)
时间窗: 30 days
Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)
次要结局
未报告次要终点