NCT07449000

Losartan for Corneal Fibrosis

Topical Losartan as Treatment to Reduce Corneal Scarring Fibrosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Universidad Autonoma de Nuevo Leon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Corneal Scarring Fibrosis

Interventions

Type	Name	Description
DRUG	Topical losartan	Drug: Topical Losartan 0.8 mg/ml ophthalmic solution, one drop applied six times daily for six months.
DRUG	Placebo Control	Drug: Balanced saline solution ophthalmic drops, one drop applied six times daily for six months.

Timeline

• Start date: 2026-02-12
• Primary completion: 2027-02-11
• Completion: 2027-03-01
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: Mexico