An interventional study of Topical losartan and Placebo Control in Corneal Scarring Fibrosis, sponsored by Universidad Autonoma de Nuevo Leon. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Universidad Autonoma de Nuevo Leon · Not applicable, Interventional, and Treatment
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.
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.
38 studies on the registry are indexed under Corneal Injuries; 8 are open to participants now.
This study's planned enrollment of 46 is above the median of 36 across 28 interventional studies indexed under Corneal Injuries.
Browse Corneal Injuries studies →Universidad Autonoma de Nuevo Leon is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
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Adults aged 18 years or older
Refusal or inability to provide written
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Topical Losartan 0.8 mg/ml ophthalmic Solution, one drop applied six times daily for six months
Drug: Topical losartan
Drug: Balanced saline solution ophthalmic drops, one drop applied six times daily for six months.
Drug: Placebo Control
Drug: Topical Losartan 0.8 mg/ml ophthalmic solution, one drop applied six times daily for six months.
Drug: Balanced saline solution ophthalmic drops, one drop applied six times daily for six months.
Change in Best Corrected Visual Acuity (BCVA)
BCVA measured using ETDRS chart and reported in LogMAR units.
Time frame: Baseline to 6 months.
Change in Contrast Sensitivity
Contrast sensitivity will be evaluated using FACT chart.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline to 6 months.
Change in corneal aberrations
Corneal scar density will be quantitatively measured using Scheimpflug corneal tomography corneal Zernike Analysis reported micron.
Time frame: Baseline to 6 months.
Change in Intraocular Pressure
Intraocular pressure will be measured using Goldmann applanation tonometry to monitor ocular safety.
Time frame: Baseline to 6 months.
Change in corneal pachymetry
Corneal pachymetry will be measeured using optical coherence tomography.
Time frame: Baseline to 6 months.
Corneal scar depth
Corneal scar depth will be evaluated using optical coherence tomography line scan.
Time frame: 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.
Time frame: Baseline to 6 months.
Treatment Adherence
Treatment adherence will be assessed based on daily patient adherence report.
Time frame: Baseline to 6 months.
Started Feb 2026 (actual). Primary completion is estimated for Feb 2027, 11 months after the start.
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Studies of the drug tested here: Losartan
Universidad Autonoma de Nuevo Leon