Efficacy, Tolerability and Comfort of 0.3% Hypromellose Eyedrops in the Pre- and Post-Operative Treatment of Patients Undergoing LASIK Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Ocular Comfort Level From Baseline to End of Study
研究概览
简要总结
This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant).
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
- 21 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 - 35
- •Both sexes
- •Seeking LASIK surgery at the Refractive Surgery Centre
- •Meeting all established criteria for appropriateness for LASIK established by the treating center
排除标准
- •Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
- •Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus
- •Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment
- •Anticipated refusal or inability to undergo planned post-operative visits or assessment
- •Failure to meet all established criteria for appropriateness for LASIK
研究组 & 干预措施
Pre-LASIK 0.3% hypromellose
干预措施: Pre-LASIK 0.3% hypromellose (Drug)
Post-LASIK 0.3% hypromellose
干预措施: Post-LASIK 0.3% hypromellose (Drug)
结局指标
主要结局
Ocular Comfort Level From Baseline to End of Study
时间窗: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.
次要结局
- Results of Schirmer's Test From Baseline to End of Study(Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery)
- Tear Breakup Time From Baseline to End of Study(Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery)