Losartan for Corneal Fibrosis

Topical Losartan as Treatment to Reduce Corneal Scarring 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.

Study Overview

• Status: Recruiting
• Conditions: Corneal Scarring Fibrosis
• Intervention / Treatment: Drug: Topical losartan; Drug: Placebo Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karim Mohamed-Noriega, Dr. med.; Phone Number: 8514 +52 8113404960; Email: karim.mohamednrg@uanl.edu.mx

Study Locations

• Mexico
  • Nueo Leon
    • Monterrey, Nueo Leon, Mexico, 64460
      • Recruiting
      • Ophthalmology Department
      • Contact: Karim Mohamed-Noriega, Dr. med.; Phone Number: 8514 +52 8113404960; Email: karim.mohamednrg@uanl.edu.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical losartan; Drug: Topical Losartan 0.8 mg/ml ophthalmic Solution, one drop applied six times daily for six months	Drug: Topical losartan; Drug: Topical Losartan 0.8 mg/ml ophthalmic solution, one drop applied six times daily for six months.
Placebo Comparator: Placebo; Drug: Balanced saline solution ophthalmic drops, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Best Corrected Visual Acuity (BCVA)	BCVA measured using ETDRS chart and reported in LogMAR units.	Baseline to 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Contrast Sensitivity	Contrast sensitivity will be evaluated using FACT chart.	Baseline to 6 months.
Change in Corneal Haze Severity	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.	Baseline to 6 months.
Change in Corneal Scar Density	Corneal scar density will be quantitatively measured using Scheimpflug corneal tomography corneal densitometry and reported in grayscale units (GSU).	Baseline to 6 months
Change in Corneal Scar Area	The area of corneal scarring will be measured using slit-lamp corneal photography and analyzed with Image J software, reported in square millimeters (mm²).	Baseline to 6 months.
Change in corneal aberrations	Corneal scar density will be quantitatively measured using Scheimpflug corneal tomography corneal Zernike Analysis reported micron.	Baseline to 6 months.
Change in Intraocular Pressure	Intraocular pressure will be measured using Goldmann applanation tonometry to monitor ocular safety.	Baseline to 6 months.
Change in corneal pachymetry	Corneal pachymetry will be measeured using optical coherence tomography.	Baseline to 6 months.
Corneal scar depth	Corneal scar depth will be evaluated using optical coherence tomography line scan.	Baseline to 6 months.
Treatment Adverse Events	Treatment adverse events will be assessed based on patient-reported ocular discomfort and recorded adverse events during follow-up visits.	Baseline to 6 months.
Treatment Adherence	Treatment adherence will be assessed based on daily patient adherence report.	Baseline to 6 months.

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Nuevo Leon
• Investigators: Principal Investigator: Karim Mohamed-Noriega, Dr. med., Universidad Autonoma de Nuevo Leon

Publications and helpful links

General Publications

• COZAAR® (losartan potassium) tablets, for oral use Initial U.S. Approval: 1995 . FDA
• PLM. (n.d.). COZAAR - Comprimidos. Medicamentos PLM. Recuperado el 9 de febrero de 2025, de https://www.medicamentosplm.com/Home/productos/cozaar.comprimidos/128/101/77344/25
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• 18. Sampaio, L. P., Martinez, V. V., Shiju, T. M., Hilgert, G. S. L., Santhiago, M. R., & Wilson, S. E. (2023). Cell Biology of Spontaneous Persistent Epithelial Defects After Photorefractive Keratectomy in Rabbits. Translational Vision Science and Technology, 12(5). https://doi.org/10.1167/tvst.12.5.15
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Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2026
• Primary Completion (Estimated): February 11, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Corneal haze; Corneal scarring; Corneal opacity; Corneal scar; Topical losartan
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Eye Diseases; Corneal Diseases; Craniocerebral Trauma; Trauma, Nervous System; Eye Injuries; Facial Injuries; Corneal Injuries; Corneal Opacity; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Imidazoles; Benzene Derivatives; Tetrazoles; Biphenyl Compounds; Losartan
• Other Study ID Numbers: OF25-00010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No