A Single Center, Randomized, Double-Masked, Placebo Controlled Study Evaluating the Safety and Efficacy of 0.25% PG101 and 1.0% PG101 in Subjects With Dry Eye Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- At least one dry eye ocular symptom
研究概览
简要总结
To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension compared to placebo when administered two times daily for 14 days in subjects diagnosed with dry eye syndrome
详细描述
The topical product PG101 is expected to be efficacious in treating the symptoms of dry eye such as discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing. Two concentrations (0.25% and 1.0%) are included in the study to determine if there is a dose response effect.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female of any race, at least 18 years of age
- •Have provided verbal and written informed consent
- •Be able and willing to follow instructions, including participation in all study assessments and visits
- •Have a reported history of dry eye syndrome
- •Have a history of use or desire to use eye drops for dry eye
- •If a woman of childbearing potential, have a negative pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period
- •Have a best corrected visual acuity of +0.70 logMAR or better in both eyes
排除标准
- •Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters
- •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1
- •Be a woman who is pregnant, nursing or planning a pregnancy
- •Have a known allergy and/or sensitivity to the test article or its components
- •Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1
研究组 & 干预措施
PG101 0.25%
Topical application of drug
干预措施: PG101 (Drug)
PG101 1.0%
Topical application of drug
干预措施: PG101 (Drug)
Placebo
Topical application of placebo
干预措施: PG101 (Drug)
结局指标
主要结局
At least one dry eye ocular symptom
时间窗: Up to 2 weeks
Dry eye ocular symptoms measured are: Ocular discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing.
次要结局
- At least one dry eye ocular sign measure.(Up to 2 weeks)