Losartan for Corneal Fibrosis

Universidad Autonoma de Nuevo Leon

Status: Enrolling

Conditions: Corneal Scarring Fibrosis

Treatments: Drug: Topical losartan; Drug: Placebo Control

Study type: Interventional

Funder types: Other

Identifiers

NCT07449000

OF25-00010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

Topical losartan

Active Comparator group

Description:

Drug: Topical Losartan 0.8 mg/ml ophthalmic Solution, one drop applied six times daily for six months

Treatment:

Drug: Topical losartan

Placebo

Placebo Comparator group

Description:

Drug: Balanced saline solution ophthalmic drops, one drop applied six times daily for six months.

Treatment:

Drug: Placebo Control