ISRCTN68968150已完成不适用
A Colateral, Double-Masked, Randomized Study to Evaluate Preservative-Free Levocabastine 0.05% Ophthalmic Solution When Compared to Preserved Levocabastin 0.05% Ophthalmic Suspension or Preservative-Free Levocabastine Ophthalmic Solution Vehicle During Allergen Challenge
aboratoire Chauvin, Bausch & Lomb Inc. (France)0 个研究点目标入组 92 人开始时间: 2010年3月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy
- •2. Volunteers
- •3. Male or female
- •4. 18-50 years old
- •5. History of allergic conjunctivitis
- •6. Normal screening ocular examination
- •7. Best corrected distance visual acuity (VA) must be 8/10 (Monoyer scale) or more
- •8. Intraocular pressure (IOP) must be <21 mm Hg
- •9. Positive screening conjunctival provocation test (CPT) including at least moderate itching and hyperaemia
- •10. Women of childbearing potential must have a negative pregnancy test
- •11. Contact lens wearers must agree to not wear contact lenses when CPTs are conducted
排除标准
- •1. Any ocular or systemic disease
- •2. Known hypersensitivity to the study drugs or their components
- •3. Allergic conjunctivitis due to an allergen other than grass pollen
- •4. Subjects who don't have discontinued use of certain medications up to 6 weeks prior to study entry
- •5. Subjects who have previously undergone hyposensitization therapy for grass pollen within 3 months prior to study entry
- •6. Subjects who have previously undergone ocular laser treatment or ocular surgery within 6 months prior to study entry
研究者
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