Effects of a Prostaglandin Analog-Based Eyelash Serum on Ocular Surface Integrity and Tear Film Stability: A Prospective Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in Tear Film Stability (A-NIBUT) After Six Weeks of Eyelash Serum Application
研究概览
简要总结
This prospective interventional study investigates the effects of a prostaglandin analog-based eyelash serum on ocular surface integrity, tear film stability, and eyelash growth over six weeks. Nineteen healthy female participants applied the serum daily, with clinical assessments performed at baseline and post-treatment. The study adhered to ethical guidelines, and parameters such as tear film stability, tear volume, ocular hyperemia, and eyelash characteristics were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female individuals aged 18 to 30 years.
- •Corrected distance visual acuity (CDVA) of 0.10 LogMAR or better in both eyes.
- •Fitzpatrick skin type III or lower.
- •No active dermatological conditions affecting the periocular area.
- •Regular use of cosmetic products (e.g., mascara, eyeliner, or eyeshadow) with no history of intolerance.
- •Willingness and ability to follow the serum application protocol for six weeks.
排除标准
- •History or diagnosis of dry eye disease or other ocular surface disorders.
- •Previous ocular surgery, trauma, or systemic conditions affecting ocular surface function.
- •Use of topical or systemic medications that could impact tear film stability.
- •Documented hypersensitivity or allergic reactions to cosmetic or ophthalmic products.
- •Presence of eyelid disorders that could interfere with eyelash growth (e.g., blepharitis, trichiasis).
- •Use of growth-enhancing serums within the past three months.
- •Pregnancy or breastfeeding at the time of enrollment.
研究组 & 干预措施
Prostaglandin Analog-Based Eyelash Serum Group
This study arm consists of healthy female participants who applied a prostaglandin analog-based eyelash serum once daily to the upper eyelid margin for six weeks. The study evaluated changes in ocular surface integrity, tear film stability, and eyelash growth. Clinical assessments were performed at baseline and post-treatment, including measurements of tear film parameters, ocular hyperemia, and intraocular pressure.
干预措施: Prostaglandin Analog-Based Eyelash Serum (Other)
结局指标
主要结局
Change in Tear Film Stability (A-NIBUT) After Six Weeks of Eyelash Serum Application
时间窗: Baseline and after six weeks of serum application
Assessment of average non-invasive tear break-up time (A-NIBUT) as an indicator of tear film stability before and after six weeks of daily prostaglandin analog-based eyelash serum application. A-NIBUT is measured using the Firefly S390I slit lamp (MediWorks, Suzhou, China), with lower values indicating increased tear film instability.
次要结局
- Change in Tear Volume (Tear Meniscus Height - TMH) After Six Weeks(Baseline and after six weeks)
- Change in Ocular Hyperemia (Conjunctival and Ciliary Hyperemia) After Six Weeks(Baseline and after six weeks)
- Change in Eyelash Length and Thickness After Six Weeks(Baseline and after six weeks)
研究者
José-María Sánchez-González
Head of Vision Science Research Group
University of Seville