NCT01337557Unknown4 期
Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses
Hom, Milton M., OD, FAAO0 个研究点目标入组 24 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 24
- 主要终点
- Questionnaire
研究概览
简要总结
The purpose of this study is to assess if BEPREVE (bepotastine besilate ophthalmic solution) 1.5% will have an effect on contact lens wear in patients with contact lens intolerance due to allergic conjunctivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •History of allergic conjunctivitis
- •History of contact lens intolerance
- •Between the ages of 18 and over inclusive.
- •Males or females
- •Patient is in generally good & stable overall health.
- •Patient likely to comply with study guidelines & study visits. Informed consent signed.
- •Are willing/able to return for all required study visits.
- •Are willing/able to follow instructions from the study investigator and his/her staff.
- •If a woman capable of becoming pregnant, agree to have urine pregnancy testing performed at screening (must be negative) and agree to use a medically acceptable form of birth control throughout the study duration and for at least one week prior to and after completion of the study. Women considered capable of becoming pregnant include all females who have experienced menarche and who have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
- •Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.
排除标准
- •Corneal refractive surgery within 6 months of this study.
- •Current use of Restasis
- •Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- •Pregnant or lactating women.
- •Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
- •Systemic or injected corticosteroids (including oral, parenteral, intravenous, rectal) 30 days;
- •Nasal or inhaled or ocular corticosteroids 14 days;
- •Nasal or inhaled ipratropium bromide (or atropine), inhaled nedocromil, or nasal, inhaled, or ophthalmic sodium cromolyn 14 days;
- •Agents with antihistaminic/anticholinergic activity (e.g. antidepressants, antipsychotics) 14 days;
- •Leukotriene pathway modifiers (Accolate, Singulair, Zyflo) 10 days;
- •Ocular anti-allergy medications including lodoxamide (Alomide), olopatadine (Patanol/Pataday), emedastine difumarate (Emadine), epinastine (Elestat), levocabastine (Livostin) 7 days;
- •Non-steroidal anti-inflammatory ophthalmics including bromfenac (Xibrom), ketorolac (Acular/Acuvail), nepafenac (Nevanac), flurbiprofen (Ocufen), suprofen (Profenal), diclofenac (Voltaren) 7 days;
- •OTC ophthalmic decongestant, antihistamine, or decongestant/antihistamine combinations 3 days;
- •Other anticholinergic agents 3 days
- •Immunotherapy injection 1 day.
研究组 & 干预措施
Bepotastine
Experimental
干预措施: Bepotastine (Drug)
结局指标
主要结局
Questionnaire
时间窗: 8 weeks
Contact lens comfort and wearing times (measured in hours)
次要结局
未报告次要终点
研究者
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