NCT02656394已完成2 期
Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101 - 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
- 状态
- 已完成
- 发起方
- Glia, LLC
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Glaucoma medication ocular side effect symptoms
研究概览
简要总结
To evaluate the safety and efficacy of 0.5% GL101 topical gel administered twice daily for 28 days in ameliorating adverse ocular side effects in patients under ongoing treatment with glaucoma medications.
详细描述
The study is to assess the safety and efficacy of a new treatment for ocular surface disease associated with the use of glaucoma medications.
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
- •Male or female of any race, at least 18 years of age at Visit 1 Screening.
- •Has provided verbal and written informed consent.
- •Be able and willing to follow instructions, including participation in all study assessments and visits.
- •Currently being treated for glaucoma using at least two medications, and be willing to continue on the same regime.
- •Suffers from at least two of the symptoms in the GLIA™ Glaucoma Medication Ocular Side Effect Symptoms Questionnaire at a severity of 2 (moderate) or more.
- •If a woman of childbearing potential, have a negative urine pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period.
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 corneal opacities and scars, dystrophies, epithelial scarring, infections, blood clots, etc.
- •Best corrected visual acuity (BCVA) at 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.
- •A woman who is pregnant, nursing an infant, or planning a pregnancy.
- •Has a known adverse reaction and/or sensitivity to the study drug or its components.
- •Routine use (more than twice a week) of a chlorinated swimming pool.
- •Unwilling or unable to cease using the following medications during the study period: Topical ocular cyclosporine (e.g. Restasis®), anti-histamines, antipsychotics, or eye gels.
- •Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.
研究组 & 干预措施
GL101
Active Comparator
GL101 topical gel
干预措施: GL101 (Drug)
Placebo
Placebo Comparator
Placebo topical gel
干预措施: Placebo (Drug)
结局指标
主要结局
Glaucoma medication ocular side effect symptoms
时间窗: Day 1 to 4 weeks
Glaucoma medication ocular side effect symptoms: * Ocular discomfort * Burning * Stinging * Conjunctival redness * Itching * Dryness * Foreign object sensation * Grittiness * Pain * Eyelid swelling * Eyelid redness * Photophobia * Excessive tearing * Crusty lids * Blurred vision
次要结局
- Glaucoma medication ocular side effect signs(Day 1 to 4 weeks)
- Other signs(Day 1 to 4 weeks)
研究者
研究点 (1)
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