NCT07676084招募中4 期
A Randomized, Investigator-Masked, Single-Center Study Evaluating Tolerability, Symptomatic Improvement, and Visual Functional Outcomes With the Use of Over-the-Counter Lubricating Eye Drops in Subjects With Dry Eye Disease
Andover Research Eye Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index (OSDI)
研究概览
简要总结
A study to evaluate the effect of over- the- counter (OTC) lubricating eye drops on tolerability, symptoms and visual outcomes in patients with dry eye disease (DED)
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
- Single (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
- 否
入选标准
- •Be at least 18 years of age, male or female
- •Able to provide written voluntary informed consent
- •Able and willing to adhere to the protocol instructions, including participation in all study visits
- •Subject-reported symptoms or history consistent with dry eye for at least 6 months prior to Screening/Baseline (Visit 1)
- •Ocular Surface Disease Index (OSDI) score >13
排除标准
- •Note: All ocular exclusion criteria apply to either eye.
- •DED secondary to destruction of conjunctival goblet cells due to ocular trauma (eg, alkali burns) or ocular or systemic condition (eg, Stevens-Johnson syndrome, ocular cicatricial pemphigoid, Vitamin A deficiency)
- •Any abnormal lid or corneal anatomy that would interfere with eyelid closure or create an irregular ocular tear film
- •Any active ocular infection, inflammation, or ocular allergy
- •Have undergone ocular surgery or laser refractive surgery within 9 months prior to Screening/Baseline (Visit 1)
- •Use of LipiFlow® procedure, intense pulse light procedure, or any kind of other procedure affecting meibomian glands within 6 months prior to Screening/Baseline (Visit 1)
- •Occlusion of the ocular puncta within 30 days prior to Screening/Baseline (Visit 1)
- •Have worn contact lenses within 3 days prior to Screening/Baseline (Visit 1) or planned wear during the study
- •Use of topical prescription products for dry eye, including topical ocular anti inflammatories (eg, cyclosporine, lifitegrast), corticosteroids, MIEBO® (perfluorohexyloctane ophthalmic solution), or TRYPTYR® (alcotremon ophthalmic solution) within 30 days prior to Screening/ Baseline (Visit 1)
- •Use of any eye drops (prescription or OTC, such as artificial tears or Lumify®) and/or TrueTear™ device (intranasal tear neurostimulator) within 24 hours prior to Screening/ Baseline (Visit 1)
- •Changes in any systemic medications known to impact tear production (eg, antihistamines, antidepressants, hormone replacement therapy, etc.) within 3 months prior to Screening/Baseline (Visit 1)
- •Have a serious or uncontrolled systemic disease (eg, diabetes, rheumatoid arthritis, lupus, hypertension, malignancy) that, in the opinion of the Investigator, will interfere with the study or interpretation of study results
结局指标
主要结局
Ocular Surface Disease Index (OSDI)
时间窗: 14 days
次要结局
未报告次要终点
研究者
研究点 (1)
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