A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Desonide 0.25% ophthalmic solution vs. Ketorolac tromethamine 0.5% ophthalmic solution in patients with Seasonal Allergic conjunctivitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- slit lamp examination
研究概览
简要总结
This study is a Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Desonide 0.25% ophthalmic solution and Ketorolac tromethamine 0.5% ophthalmic solution in 100 patients with Seasonal Allergic conjunctivitis. Date of first enrollment will be 12 April 2010. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The primary outcome measures will be slit lamp examination at day 0, Day 3, Day 7 and Day 14. The secondary outcome measures will be assessed Redness of eye, Ocular itching, eyelid swelling, tearing, photophobia, mucous discharge, foreign body sensation at Day 0, Day 3, Day 7 and Day 14, safety and tolerability at Day 0, Day 3, Day 7 and Day 14 & Global assessment Day 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •History of seasonal allergic conjunctivitis.
- •Presence of bilateral ocular itching/conjunctival hyperemia (redness) at baseline.
- •Written informed consent to participate in the trial.
排除标准
- •Patients < 18 & > 60 years.
- •A history of hypersensitivity to corticosteroids.
- •Active bacterial or viral conjunctivitis or history of ocular herpes.
- •Presence or history of severe dry eye.
- •Use of contact lenses during the course of the study.
- •Bestcorrected visual acuity (Snellen) in either eye worse than 20/100.
- •History of ocular surgery or laser within the previous 6 months;
- •Use of topical (ocular) or systemic corticosteroids within 2 weeks before the start of the study;
- •Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.
- •Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
结局指标
主要结局
slit lamp examination
时间窗: Day 0, Day 3, Day 7 and Day 14.
次要结局
- safety and tolerability(Day 0,Day 3, Day 7 and Day 14.)
- Redness of eye, Ocular itching, eyelid swelling, tearing, photophobia, mucous discharge, foreign body sensation(Day 0, Day 3, Day 7 and Day 14.)
- Global assessment(Day 14)