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NCT Number: NCT07449000

Losartan for Corneal Fibrosis

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.

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Key information

Conditions

Corneal Scarring Fibrosis Corneal Diseases Corneal Injuries Corneal Opacity Craniocerebral Trauma Eye Diseases Eye Injuries Facial Injuries Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmology Department

Monterrey, Nueo Leon, 64460, Mexico

Location status: Recruiting

Location contact

Karim Mohamed-Noriega, Dr. med.

CONTACT

[email protected]

+52 8113404960 ext. 8514

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Topical losartan

Drug

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

Placebo Control

Drug

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

Primary outcomes

  1. Change in Best Corrected Visual Acuity (BCVA)

    Time frame: Baseline to 6 months.

    BCVA measured using ETDRS chart and reported in LogMAR units.

Secondary outcomes

  1. Change in Contrast Sensitivity

    Time frame: Baseline to 6 months.

    Contrast sensitivity will be evaluated using FACT chart.

  2. Change in Corneal Haze Severity

    Time frame: Baseline to 6 months.

    Corneal haze will be assessed using the Fantes Corneal Haze Grading Scale, evaluated by slit-lamp biomicroscopy. The scale ranges from 0 to 4.

    Grade 0: Clear with no opacity seen by any method of microscopic slit-lamp examination.

    Grade 0.5: Trace or faint haze seen only by indirect, broad tangential illumination.

    Grade 1: Haze of minimal density seen with difficulty with direct or diffuse examination.

    Grade 2: Mild haze easily visible with direct focal slit-lamp illumination. Grade 3: Moderate opacity that partially obscures details of the iris. Grade 4: Severe opacity that completely obscures the details of intraocular structures.

    The minimum possible score is 0 and the maximum possible score is 4. Higher scores indicate greater corneal opacity and worse clinical outcome.

  3. Change in Corneal Scar Density

    Time frame: Baseline to 6 months

    Corneal scar density will be quantitatively measured using Scheimpflug corneal tomography corneal densitometry and reported in grayscale units (GSU).

  4. Change in Corneal Scar Area

    Time frame: Baseline to 6 months.

    The area of corneal scarring will be measured using slit-lamp corneal photography and analyzed with Image J software, reported in square millimeters (mm²).

  5. Change in corneal aberrations

    Time frame: Baseline to 6 months.

    Corneal scar density will be quantitatively measured using Scheimpflug corneal tomography corneal Zernike Analysis reported micron.

  6. Change in Intraocular Pressure

    Time frame: Baseline to 6 months.

    Intraocular pressure will be measured using Goldmann applanation tonometry to monitor ocular safety.

  7. Change in corneal pachymetry

    Time frame: Baseline to 6 months.

    Corneal pachymetry will be measeured using optical coherence tomography.

  8. Corneal scar depth

    Time frame: Baseline to 6 months.

    Corneal scar depth will be evaluated using optical coherence tomography line scan.

  9. Treatment Adverse Events

    Time frame: Baseline to 6 months.

    Treatment adverse events will be assessed based on patient-reported ocular discomfort and recorded adverse events during follow-up visits.

  10. Treatment Adherence

    Time frame: Baseline to 6 months.

    Treatment adherence will be assessed based on daily patient adherence report.

Study contacts

Contact information is provided by the study sponsor or research team.

Karim Mohamed-Noriega, Dr. med.

CONTACT

[email protected]

+52 8113404960 ext. 8514

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Registry information

Official study title

Topical Losartan as Treatment to Reduce Corneal Scarring Fibrosis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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