A Single-Center, Masked, Randomized Study Comparing Bepreve (Bepotastine Besilate) 1.5% - H1 Specific Antihistamine vs. Alrex (Loteprednol Etabonate) 0.2% - Corticosteroid in Subjects With Moderate to Severe Allergic Conjunctivitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change From Baseline in Ocular Itching at 14 Days
研究概览
简要总结
Allergic conjunctivitis (AC) afflicts approximately 20% of the US population. Typically, patients manifest symptoms in the spring, summer and fall, when airborne allergens are at their peak. Patients may also be afflicted year-round, if sensitive to allergens such as dust mites or pet dander. Signs and symptoms of allergic conjunctivitis are conjunctival hyperemia, ocular itching, conjunctival and eyelid edema, papillary hypertrophy, tearing and burning.
This is a randomized clinical study to evaluate the efficacy of Bepreve® (bepotastine besilate 1.5% ophthalmic solution) compared to Alrex® (loteprednol etabonate 0.2%) in the treatment of moderate to severe allergic conjunctivitis in patient over the age of 18 years. The study will be a two-week study with four visits. Ocular signs (eye redness( and symptoms (itching) will be monitored as outcome variables.
详细描述
Investigator and Study Center:
Judy Tong, OD Eye Care Center Southern California College of Optometry
Test Product, Dose and Mode of Administration:
Bepreve (bepotastine besilate ophthalmic solution) 1.5% bid ou vs. Alrex (loteprednol etabonate ophthalmic suspension) 0.2% qid ou
Study Title:
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
- Single (Investigator)
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
- •Moderate to severe allergic subjects (≥ 2.5 on a 0.0 to 4.0 itching scale AND
- •> grade 2.0 bulbar redness using validated (Efron) scale)
- •Must be able to understand and sign an informed consent form that has been approved by the Institutional Review Board (IRB).
- •Can comply with instillation of study drug
- •Must be able to comply with the visit schedule and other requirements of the study.
排除标准
- •Subjects who use daily wear (5-7 days / week, 6-16 hours/day)25 disposable soft hydrogel or silicone hydrogel contact lenses will be included in the study if they have been consistently wearing the same brand and have been using the same care solution for one month or longer. They will be asked to not wear their soft contact lenses to the eligibility visit (three days of no lens wear) and be willing to discontinue lens wear during the two weeks of the study because of the incompatibility of medicated eye drop instillation with contact lens wear and the potential confounding effect of contact lenses and care solutions.
- •Active inflammation of the cornea, iris, anterior chamber
- •Active or suspected herpetic eye disease (simplex, vaccinia, varicella)
- •Active or suspected mycobacterial or acanthamoeba infection
- •Active for suspected fungal disorders of the eye
- •Persistent and significant dry eye syndrome
- •Known allergy, contraindications or hypersensitivity to loteprednol, bepotastine, or its components
- •Pregnancy or breast-feeding
- •Use of topical eye drops, topical or systemic antihistamines, topical, nasal or systemic corticosteroids, immunosuppressive or immunomodulating agents, decongestants, aspirin, or non-steroidal antiinflammatory (NSAIDs) during the two weeks prior to the study.
- •Participation in any other study within 30 days of this study.
研究组 & 干预措施
Bepreve
1.5% bepotastine besilate, drops, twice per day, for two weeks
干预措施: bepotastine besilate, 1.5% (Drug)
Alrex
treatment with 0.2 % loteprednol etabonate, drops, four times per day
干预措施: Loteprednol etabonate (Drug)
结局指标
主要结局
Change From Baseline in Ocular Itching at 14 Days
时间窗: Change from Baseline in Ocular Itching at 14 Days
Ocular Itching Scale. Scale is 0 - 4 in 0.5 scale unit increments. 0 equals no Itch. 4 equals most severe itch. No calculation details are necessary as the change is calculated as the latest time point minus the earliest time point.
次要结局
未报告次要终点