Losartan for Corneal Fibrosis
ConditionCorneal Scarring Fibrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Autonoma de Nuevo Leon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Refusal or inability to provide written informed consent
Presence of corneal epithelial defect or friable epithelium
Age under 18 years
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Topical losartan
DrugDrug: Topical Losartan 0.8 mg/ml ophthalmic solution, one drop applied six times daily for six months.
Placebo Control
DrugDrug: Balanced saline solution ophthalmic drops, one drop applied six times daily for six months.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Topical losartanActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Best Corrected Visual Acuity (BCVA)
BCVA measured using ETDRS chart and reported in LogMAR units.
Time frame
Baseline to 6 months.Secondary outcomes
1
Change in Contrast Sensitivity
Contrast sensitivity will be evaluated using FACT chart.
Time frame
Baseline to 6 months.2
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.3
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 months4
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.Sponsors and contacts
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Source ClinicalTrials.gov