NCT03198000已完成3 期
A Single-Center, Randomized, Controlled Study to Evaluate the Efficacy of Two Investigational OTC Eye Drops in Healthy Adults With Red Eye
Johnson & Johnson Consumer Inc. (J&JCI)1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年6月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application
研究概览
简要总结
This is a single center, double-blinded study designed to demonstrate the therapeutic equivalence of over-the-counter eye drops in healthy adults with red eyes.
详细描述
Eligible participants will use assigned eye drop products as directed. Participants will be required to attend 2 consecutive clinic visits. Assessments for eye redness and eye comfort will be completed. Participants will complete brief questionnaires about their eyes.
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
- Double (Participant, 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
- •Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
- •Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research
- •Male or female of any race or ethnicity, aged 18 years and older;
- •Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);
- •Able to read and understand English;
- •Healthy subjects with redness in both eyes
- •History of topical ocular drugs or desire to use within the last 6 months;
- •Ocular health within normal limits,
- •Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Screening/Baseline Visit 1.
排除标准
- •Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
- •Known sensitivity, allergy or contraindications to any investigational product ingredient;
- •Females who are pregnant, planning to become pregnant or breastfeeding during the study;
- •Subjects who were previously screened and determined to be ineligible for the study;
- •Use of a therapeutic eye treatment (over-the-counter or prescription) within 2 days of the Screening/Baseline visit (Visit 1) and throughout study participation;
- •Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);
- •Relative, partner or staff of any clinical research site personnel;
- •Active infection of any type at the start of the study; particularly, presence of active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection;
- •Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;
- •Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
- •Has a compromised immune system;
- •Has any acute or chronic, medical or psychiatric conditions
- •Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;
- •Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;
- •Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.
研究组 & 干预措施
Formula # 13418-148
Experimental
干预措施: F# 13418-148 Eye Drops (Drug)
Formula # 13418-158
Experimental
干预措施: F#13418-158 Eye Drops (Drug)
Control Formula # PF004390
Active Comparator
干预措施: F# PF-004390 Eye Drops (Drug)
结局指标
主要结局
Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application
时间窗: Baseline to 60 seconds after first product application
Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
Percentage of Participants With Response to Redness at 60 Seconds After First Product Application
时间窗: Baseline to 60 seconds after first product application
The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
次要结局
- Change From Baseline in Ocular Comfort at 10 Hours After First Product Application(Baseline to 10 hours after first product application)
- Change From Baseline in Ocular Comfort at 12 Hours After First Product Application(Baseline to 12 hours after first product application)
- My Eye Appears to Sparkle - 10 Hours After First Application(10 hours after first application)
- Clinician Assessment of Baseline Redness(Baseline)
- My Eye Feels Hydrated - 2 Minutes After First Application(2 minutes after first application)
- My Eye Feels Refreshed - 2 Minutes After First Application(2 minutes after first application)
- The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application(2 minutes after first application)
- Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application(Baseline to 60 seconds after first product application)
- My Eye Feels Hydrated - Baseline(Baseline)
- The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application(10 hours after first application)
- The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application(12 hours after first application)
- Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application(Baseline to 30 seconds after first product application)
- Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application(Baseline to 2 minutes after first product application)
- My Eye Feels Hydrated - 10 Hours After First Application(10 hours after first application)
- My Eye Feels Hydrated - 12 Hours After First Application(12 hours after first application)
- My Eye Feels Refreshed - 10 Hours After First Application(10 hours after first application)
- The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application(12 hours after first application)
- My Eye Feels Cool - 12 Hours After First Application(12 hours after first application)
- My Eye Feels Refreshed - 12 Hours After First Application(12 hours after first application)
- The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application(2 minutes after first application)
- The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application(10 hours after first application)
- My Eye Appears Healthy - 2 Minutes After First Application(2 minutes after first application)
- My Eye Feels Cool - 2 Minutes After First Application(2 minutes after first application)
- The Appearance of my Eye Gives me Confidence to Approach Others - Baseline(Baseline)
- The Appearance of my Eye Can Show How I Really Feel - Baseline(Baseline)
- My Eye Appears Healthy - Baseline(Baseline)
- My Eye Appears Healthy - 10 Hours After First Application(10 hours after first application)
- My Eye Appears Healthy - 12 Hours After First Application(12 hours after first application)
- My Eye Feels Cool - 10 Hours After First Application(10 hours after first application)
- My Eye Appears to Sparkle - Baseline(Baseline)
- My Eye Appears to Sparkle - 12 Hours After First Application(12 hours after first application)
- My Eye Appears to Sparkle - 2 Minutes After First Application(2 minutes after first application)
研究者
研究点 (1)
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