Topical Losartan as Treatment to Reduce Corneal Scarring Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
This is a prospective, randomized, double-blinded, controlled clinical trial designed to evaluate the efficacy and safety of topical losartan in improving visual acuity, contrast sensitivity and reducing corneal densitometry, corneal aberrations and corneal scarring severity in adult patients with corneal scars of different etiologies. Participants will be randomly assigned to receive either topical losartan 0.8 mg/mL or placebo eyedrops 6 times per day for six months.
详细描述
Corneal scarring is a significant cause of visual impairment worldwide, with limited conservative treatment options. Corticosteroids are commonly used but are associated with important adverse effects. Losartan, an angiotensin II receptor blocker, has demonstrated antifibrotic effects through inhibition of TGF-β signaling in experimental studies.
This study aims to evaluate the safety and efficacy of topical losartan in improving visual function and corneal transparency in patients with corneal scarring fibrosis. Outcomes include changes in best-corrected visual acuity measured using the ETDRS chart, contrast sensitivity with FACT chart, corneal scar area calculated with ImageJ, corneal density assessed by Scheimpflug corneal densitometry, corneal aberrations using Zernike Analysis and clinical corneal scar severity evaluated using slit-lamp biomicroscopy with Fantes haze grading, compared with placebo. A total of 46 adult patients with stable corneal scars will be enrolled and followed for six months.
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
- Double (Participant, 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
- •Inclusion Criteria:
- •Adults aged 18 years or older
- •Presence of corneal scar with a duration of at least 1 month
- •Corneal scars of any etiology
- •Corneal scars with or without corneal neovascularization
- •Stable corneal scar without epithelial defect
- •No active treatment for the underlying condition for at least 1 month
排除标准
- •Refusal or inability to provide written informed consent
- •Presence of corneal epithelial defect or friable epithelium
- •Age under 18 years
- •Pregnancy
- •Known allergy or hypersensitivity to losartan
研究组 & 干预措施
Placebo
Drug: Balanced saline solution ophthalmic drops, one drop applied six times daily for six months.
干预措施: Placebo Control (Drug)
Topical losartan
Drug: Topical Losartan 0.8 mg/ml ophthalmic Solution, one drop applied six times daily for six months
干预措施: Topical losartan (Drug)
结局指标
主要结局
Change in Best Corrected Visual Acuity (BCVA)
时间窗: Baseline to 6 months.
BCVA measured using ETDRS chart and reported in LogMAR units.
次要结局
- Change in Contrast Sensitivity(Baseline to 6 months.)
- Change in Corneal Haze Severity(Baseline to 6 months.)
- Change in Corneal Scar Density(Baseline to 6 months)
- Change in Corneal Scar Area(Baseline to 6 months.)
- Change in corneal aberrations(Baseline to 6 months.)
- Change in Intraocular Pressure(Baseline to 6 months.)
- Change in corneal pachymetry(Baseline to 6 months.)
- Corneal scar depth(Baseline to 6 months.)
- Treatment Adverse Events(Baseline to 6 months.)
- Treatment Adherence(Baseline to 6 months.)
研究者
Karim Mohamed-Noriega
Principal Investigator
Universidad Autonoma de Nuevo Leon