Randomized, Double-Masked, Parallel Group Study of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease Assessing Safety and Efficacy Over 28 Days
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 47
- 试验地点
- 7
- 主要终点
- Change From Baseline (Visit 2) to Day 29 (Visit 4) in the Subject-reported Dry Eye Symptom Questionnaire.
研究概览
简要总结
The purpose of this study is to evaluate the effect of treatment with 0.017% P-321 on Dry Eye Symptoms.
详细描述
This is a multi-center, randomized, double-masked, placebo-controlled, parallel group Phase 2b trial designed to evaluate symptoms and signs in subjects with mild to moderate dry eye disease. Eligible patients, will be treated with placebo during 2-week placebo run-in period. Subjects will then be randomly assigned in a double-masked, 1:1 ratio to either 0.017% P-321 Ophthalmic Solution or placebo TID for 28 days. This study is designed to evaluate the changes in symptoms. Safety will be assessed throughout the study by adverse events.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent
- •Male or female subjects aged 18 to 80 years, inclusive
- •Have a history of dry eye disease (DED) in both eyes
- •Be on stable regimens of other needed medications
- •Have a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS)
- •Have reported symptoms
- •Have the following signs in at least one eye: Schirmer score without anesthesia of >1 and <10 mm at 5 minutes and staining of conjunctival and corneal areas of the eye.
- •Have normal lid anatomy
排除标准
- •Have undergone refractive eye surgery in the past 12 months
- •Have undergone previous eyelid surgery in either eye (External blepharoplasty not resulting in exposure or abnormal blinking is allowed)
- •Have lid irregularities or deformities
- •Have a history of glaucoma, a history of an elevated lOP within the past year, or an lOP in either eye > 25 mmHg at the Screening Visit (Visit 1)
- •Have any clinically significant, uncontrolled, or unstable medical or surgical conditions that could affect his or her ability to participate
- •Have permanent punctal plugs, punctal occlusion, or history of nasolacrimal duct obstruction. Removable punctal plugs are allowed if they have been used regularly for at least 60 days prior to the screening visit. However, if a plug comes out during the study it must be promptly replaced.
- •Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study Eye
- •Are pregnant or breast feeding
- •Use of any investigational product or device within 28 days prior to the Screening Visit or during the study
研究组 & 干预措施
0.017% P-321 Ophthalmic Solution
0.017% P-321 Ophthalmic Solution TID for 28 days.
干预措施: P-321 Ophthalmic Solution (Drug)
Placebo
P-321 Ophthalmic Solution Placebo TID for 28 days.
干预措施: P-321 Ophthalmic Solution placebo (Drug)
结局指标
主要结局
Change From Baseline (Visit 2) to Day 29 (Visit 4) in the Subject-reported Dry Eye Symptom Questionnaire.
时间窗: Baseline to Day 29
Dry Eye symptoms were obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes separate Visual Analog Scales (VAS) for the frequency and the Severity of symptoms. The scores range from 0 to 100 where 0 = Rarely or Very Mild, and 100 = All the Time or Very Severe for the Frequency and Severity of the symptoms, respectively. The Global Score as reported in the Primary Outcome is obtained by taking the square root of the product of the frequency score multiplied by the severity score. Negative change from baseline indicates improvement.
次要结局
- Change From Baseline (Visit 2) to Day 29 in Symptom Frequency Scores(Baseline to Day 29)
- Change From Baseline (Visit 2) to Day 29 in Symptom Severity Scores(Baseline to Day 29)
- Change From Baseline to Day 29 in Fluorescein Staining of the Cornea.(Baseline to Day 29)
- Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva.(Baseline to Day 29)
- Number of Participants With at Least 20% Improvement in Symptoms From Baseline to Day 29(Baseline to Day 29)
- Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score.(Baseline to Day 15)