NCT04884217Unknown2 期
Treatment of Dry Eye Disease Using Pro-ocular™ - A Proof of Concept, Safety, and Efficacy Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
研究概览
简要总结
To evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks in treatment of Dry Eye Disease
详细描述
Pro-ocular™ 1% topical gel his demonstrated efficacy in rapidly reducing or eliminating dry eye symptoms, and after multiple doses, the signs and symptoms of ocular surface disease including dry eye disease.
Study DE-2 is single center, randomized, double-masked, placebo-controlled, parallel-group study designed to evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks for treatment of Dry Eye Disease. The approximately 80 subjects will be randomized 1:1, active drug:placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of any race, at least 20 years of age at Visit 1 Screening.
- •Has a subject reported history (including physician diagnosis) of dry eye disease in both eyes for at least 3 months prior to Visit
- •Has SANDE score ≥50 in either frequency or severity of symptoms of dryness and/or irritation at Visit
- •Have all of the following in the same eye at Visit 1:
- •Fluorescein Tear Break-Up Time of ≤5 seconds.
- •Corneal fluorescein staining score of moderate or more in any field (inferior, superior or central).
- •Report a severity score of moderate or more on ocular dryness and at least one of the other symptoms on the GLIA Ocular Surface Disease Symptoms Questionnaire.
- •Has provided written informed consent.
- •Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.
排除标准
- •Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as but not limited to corneal opacities and scars, dystrophies, epithelial scarring, infections, history of blood clots, etc.
- •Has infections, or inflammatory skin lesion in or around the dosing area.
- •Best corrected visual acuity baseline <20/
- •Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study.
- •Wear contact lens within 7 days prior to Visit
- •Anticipate change of vision correction or anticipate any ocular procedures during study period.
- •A woman who is pregnant or testing positive in the blood pregnancy test at screening, nursing an infant, or planning a pregnancy.
- •Has a known adverse reaction and/or sensitivity to the study drug or its components.
- •Use of topical ocular cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), diquafosol (Diquas®), eye gels, eye ointments, any administration route of steroids, anti-histamines, antipsychotics, antidepressants and NSAIDs within 30 days prior to Visit
- •Routine use (more than once a week) of a chlorinated swimming pool during study period.
- •Unwilling or unable to cease using the following medications during the study period (from Visit 1 to Visit 6): Topical ocular cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), diquafosol (Diquas®), eye gels, eye ointments, any administration route of steroids, anti-histamines, antipsychotics, antidepressants and NSAIDs..
- •Unwilling to cease the use of sunscreen and face scrubs on the forehead or eye area during study period.
- •Smoke within 3 months prior to Visit
- •Ongoing glaucoma treatment within 30 days prior to Visit 1 and during study period.
- •Currently enrolled in an investigational drug or device study within 30 days prior to Visit 1 and during study period.
研究组 & 干预措施
Pro-ocular™
Active Comparator
Pro-ocular™ Topical Gel
干预措施: Pro-ocular™ Topical Gel (Drug)
Placebo
Placebo Comparator
Placebo Topical Gel
干预措施: Placebo Topical Gel (Drug)
结局指标
主要结局
Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
时间窗: 2 weeks
Change from baseline in SANDE symptoms frequency score (0-100 worst)
Change in corneal (central) fluorescein staining score
时间窗: 4 weeks
Change from baseline in score on a visual analog scale (0-10 worst)
次要结局
- Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score(12 weeks)
- Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score(12 weeks)
- Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score(12 weeks)
- Change in Bulbar redness score by Keratograph®(12 weeks)
- Change in corneal (superior) fluorescein staining score(12 weeks)
- Change in corneal fluorescein staining sum of scores(12 weeks)
- Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores(12 weeks)
- Change in Meibography score by Keratograph®(12 weeks)
- Change in Tear Meniscus Height (TMH) by Keratograph®(12 weeks)
- Change in corneal (central) fluorescein staining score(12 weeks)
- Change in lissamine green staining (corneal and conjunctival) sum of scores(12 weeks)
- Change in conjunctival hyperemia (by slit lamp biomicroscopy)(12 weeks)
- Change in conjunctival fluorescein staining sum of scores(12 weeks)
- Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score(12 weeks)
- Change in Tear Film Grading by TearScan examination(12 weeks)
- Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)(12 weeks)
- Change in corneal (inferior) fluorescein staining score(12 weeks)
- Change in tear film osmolarity by TearLab™ osmolarity system(2 weeks)
- Change in corneal sensitivity using Cochet-Bonnet esthesiometer(12 weeks)
- Change in Fluorescein Tear Break-Up Time (FBUT)(12 weeks)
研究者
研究点 (1)
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