Topical losartan eyedrops for corneal scarring
Topical Losartan as Treatment to Reduce Corneal Scarring Fibrosis
NA · Universidad Autonoma de Nuevo Leon · NCT07449000
This trial will test whether losartan eye drops improve vision and reduce corneal scarring in adults with stable corneal scars.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Autonoma de Nuevo Leon (other) |
| Locations | 1 site (Monterrey, Nueo Leon) |
| Trial ID | NCT07449000 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled trial will assign 46 adults with stable corneal scars to receive topical losartan 0.8 mg/mL or placebo six times daily for six months. Key outcomes include changes in best-corrected visual acuity and contrast sensitivity, with secondary measures of corneal scar area, corneal densitometry, corneal aberrations, and clinical scar severity. Measurements will use ETDRS charts, FACT contrast testing, Scheimpflug densitometry, Zernike analysis, ImageJ scar area calculations, and slit-lamp Fantes grading. Safety and adverse events will be monitored throughout the treatment period.
Who should consider this trial
Good fit: Adults aged 18 years or older with a stable corneal scar of at least one month duration, no epithelial defect, and no known allergy to losartan are the ideal candidates.
Not a fit: Patients with active corneal epithelial defects, unstable or recently treated corneal disease, pregnancy, or known hypersensitivity to losartan are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, topical losartan could improve visual acuity and corneal transparency and might reduce the need for surgical treatments such as corneal transplantation.
How similar studies have performed: Preclinical and laboratory studies have shown antifibrotic effects of losartan on corneal tissue, but clinical evidence for topical losartan in humans is limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 * Exclusion Criteria: * 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
Where this trial is running
Monterrey, Nueo Leon
- Ophthalmology Department — Monterrey, Nueo Leon, Mexico (RECRUITING)
Study contacts
- Principal investigator: Karim Mohamed-Noriega, Dr. med. — Universidad Autonoma de Nuevo Leon
- Study coordinator: Karim Mohamed-Noriega, Dr. med.
- Email: karim.mohamednrg@uanl.edu.mx
- Phone: +52 8113404960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Corneal Scarring Fibrosis, Corneal scar, Corneal scarring, Corneal haze, Corneal opacity, Topical losartan