Efficacy of Low-Level Light Therapy in Combination With Topical Non-Steroidal Immunosuppressants for the Treatment of Dry Eye Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Ocular surface disease index (OSDI)
研究概览
简要总结
The objective of the study is to evaluate the effectiveness of Low-level light therapy (LLLT) in combination with either topical Cyclosporine A (CsA) or topical Tacrolimus, using each non-steroidal immunosuppressant as an active control.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants were masked to CsA and Tacrolimus, but not to LLLT.
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Ocular Surface Disease Index (OSDI) score > 13; (2) non-invasive tear film break-up time (NIBUT) < 10 seconds; and (3) tear meniscus height < 0.25 mm.
排除标准
- •(1) structural abnormalities of the eyelids; (2) active blepharitis; (3) corneal disorders that could interfere with study assessments, such as active corneal infections or corneal dystrophies; (4) active ocular allergy; (5) history of procedures for DED treatment within the previous 12 months, such as eyelid exfoliation, thermal eyelid therapies, light therapies, or quantum molecular resonance (QMR); (6) history of intraocular or laser ocular surgery within the past 5 years; (7) current use of topical antibiotics or anti-inflammatory agents; (8) diagnosis of systemic autoimmune disease; (9) contact lens wear; (10) pregnancy or lactation; and (11) inability to understand or provide informed consent.
研究组 & 干预措施
CsA
CsA 0.1% twice per day
干预措施: Topical Cyclosporine A (Drug)
Tacrolimus
Tacrolimus 0.1% twice per day
干预措施: Topical tacrolimus (Drug)
LLLT-CsA
Three 15-minute sessions of LLLT were performed at weekly intervals. The treatment was delivered with a wavelength of 625 nm and a radiance of 35 mW/cm², resulting in a total energy dose of approximately 32 J/cm² applied to the facial and eyelid regions with eyes closed.
CsA 0.1% twice per day.
干预措施: Low-level light therapy (LLLT) (Device)
LLLT-CsA
Three 15-minute sessions of LLLT were performed at weekly intervals. The treatment was delivered with a wavelength of 625 nm and a radiance of 35 mW/cm², resulting in a total energy dose of approximately 32 J/cm² applied to the facial and eyelid regions with eyes closed.
CsA 0.1% twice per day.
干预措施: Topical Cyclosporine A (Drug)
LLLT-Tacrolimus
Three 15-minute sessions of LLLT were performed at weekly intervals. The treatment was delivered with a wavelength of 625 nm and a radiance of 35 mW/cm², resulting in a total energy dose of approximately 32 J/cm² applied to the facial and eyelid regions with eyes closed.
Tacrolimus 0.1% twice per day.
干预措施: Low-level light therapy (LLLT) (Device)
LLLT-Tacrolimus
Three 15-minute sessions of LLLT were performed at weekly intervals. The treatment was delivered with a wavelength of 625 nm and a radiance of 35 mW/cm², resulting in a total energy dose of approximately 32 J/cm² applied to the facial and eyelid regions with eyes closed.
Tacrolimus 0.1% twice per day.
干预措施: Topical tacrolimus (Drug)
结局指标
主要结局
Ocular surface disease index (OSDI)
时间窗: From baseline visit to the end of follow-up (12 months)
A standardized questionnaire designed to assess the symptoms of dry eye disease and their impact on vision-related functioning. It consists of 12 items that evaluate the frequency of symptoms, environmental triggers, and functional limitations over the previous week. The OSDI provides a score from 0 to 100, with higher scores indicating more severe symptoms.
次要结局
- Non-invasive tear film break-up time (NIBUT)(From baseline visit to the end of follow-up (12 months))
- Tear meniscus height (TMH)(From baseline visit to the end of follow-up (12 months))
研究者
Antonio Ballesteros Sánchez
OD, PhD
University of Seville