Corneal Scarring FibrosisNCT07449000
Losartan for Corneal Fibrosis
A study testing Topical losartan in people with Corneal Scarring Fibrosis, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Scarring Fibrosis
- What is being tested?
- Topical losartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteMexico
- Study dates
- 12 Feb 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Ophthalmology Department
Monterrey, Nueo Leon, 64460
Karim Mohamed-Noriega, Dr. med., +52 8113404960 ext. 8514, karim.mohamednrg@uanl.edu.mx
About this study
Official title: 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.
Read the 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.
- Conditions
- Corneal Scarring Fibrosis
- Being tested
- Topical losartan, Placebo Control
- Keywords
- Corneal scar, Corneal scarring, Corneal haze, Corneal opacity, Topical losartan
- Medical subject headings
- Corneal Injuries, Corneal Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical losartanDrug
Drug: Topical Losartan 0.8 mg/ml ophthalmic solution, one drop applied six times daily for six months.
Placebo ControlDrug
Drug: Balanced saline solution ophthalmic drops, one drop applied six times daily for six months.
| Study group | Role | What they receive |
|---|---|---|
| Topical losartan | Active comparator | Drug: Topical Losartan 0.8 mg/ml ophthalmic Solution, one drop applied six times daily for six months Receives: Drug: Topical losartan |
| Placebo | Placebo comparator | Drug: Balanced saline solution ophthalmic drops, one drop applied six times daily for six months. Receives: Drug: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best Corrected Visual Acuity (BCVA)
BCVA measured using ETDRS chart and reported in LogMAR units.
Measured: Baseline to 6 months.
Secondary outcomes (10)
Change in Contrast Sensitivity
Contrast sensitivity will be evaluated using FACT chart.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline to 6 months.
Change in corneal aberrations
Corneal scar density will be quantitatively measured using Scheimpflug corneal tomography corneal Zernike Analysis reported micron.
Measured: Baseline to 6 months.
Change in Intraocular Pressure
Intraocular pressure will be measured using Goldmann applanation tonometry to monitor ocular safety.
Measured: Baseline to 6 months.
Change in corneal pachymetry
Corneal pachymetry will be measeured using optical coherence tomography.
Measured: Baseline to 6 months.
Corneal scar depth
Corneal scar depth will be evaluated using optical coherence tomography line scan.
Measured: 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.
Measured: Baseline to 6 months.
Treatment Adherence
Treatment adherence will be assessed based on daily patient adherence report.
Measured: Baseline to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start12 Feb 2026
- Primary completion11 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Corneal Scarring FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Mohamed-Noriega, Universidad Autonoma de Nuevo Leon
- Investigators
- Karim Mohamed-Noriega, Dr. med., Principal investigator, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449000
- Sponsor's protocol ID
- OF25-00010
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Mauer M, Zinman B, Gardiner R, Suissa S, Sinaiko A, Strand T, Drummond K, Donnelly S, Goodyer P, Gubler MC, Klein R. Renal and retinal effects of enalapril and losartan in type 1 diabetes. N Engl J Med. 2009 Jul 2;361(1):40-51. doi: 10.1056/NEJMoa0808400.
PubMed 19571282Burnier M, Waeber B, Brunner HR. Clinical pharmacology of the angiotensin II receptor antagonist losartan potassium in healthy subjects. J Hypertens Suppl. 1995 Jul;13(1):S23-8. doi: 10.1097/00004872-199507001-00003.
PubMed 18800452Zandbergen AA, Baggen MG, Lamberts SW, Bootsma AH, de Zeeuw D, Ouwendijk RJ. Effect of losartan on microalbuminuria in normotensive patients with type 2 diabetes mellitus. A randomized clinical trial. Ann Intern Med. 2003 Jul 15;139(2):90-6. doi: 10.7326/0003-4819-139-2-200307150-00008.
PubMed 12859158Kubba S, Agarwal SK, Prakash A, Puri V, Babbar R, Anuradha S. Effect of losartan on albuminuria, peripheral and autonomic neuropathy in normotensive microalbuminuric type 2 diabetics. Neurol India. 2003 Sep;51(3):355-8.
PubMed 1465243745. Pucker AD, Frogozo M, Malooley MM, Harthan JS. Point-Counter Point: Treating Corneal Haze with 0.8 mg/mL Topical Losartan. Clinical Insights in Eyecare. 2024;2(5).
Rodgers EG, Al-Mohtaseb Z, Chen AJ. Topical Losartan for Treating Corneal Haze After Ultraviolet-A/Riboflavin Collagen Cross-Linking. Cornea. 2024 Sep 1;43(9):1165-1170. doi: 10.1097/ICO.0000000000003527. Epub 2024 Mar 22.
PubMed 38573840Sampaio LP, Hilgert GSL, Shiju TM, Murillo SE, Santhiago MR, Wilson SE. Topical losartan inhibits corneal scarring fibrosis and collagen type IV deposition after Descemet's membrane-endothelial excision in rabbits. Exp Eye Res. 2022 Mar;216:108940. doi: 10.1016/j.exer.2022.108940. Epub 2022 Jan 21.
PubMed 35074340Sampaio LP, Villabona-Martinez V, Shiju TM, Santhiago MR, Wilson SE. Topical Losartan Decreases Myofibroblast Generation But Not Corneal Opacity After Surface Blast-Simulating Irregular PTK in Rabbits. Transl Vis Sci Technol. 2023 Sep 1;12(9):20. doi: 10.1167/tvst.12.9.20.
PubMed 37750746Sampaio LP, Hilgert GSL, Shiju TM, Santhiago MR, Wilson SE. Losartan Inhibition of Myofibroblast Generation and Late Haze (Scarring Fibrosis) After PRK in Rabbits. J Refract Surg. 2022 Dec;38(12):820-829. doi: 10.3928/1081597X-20221026-03. Epub 2022 Dec 1.
PubMed 36476304Sampaio LP, Hilgert GSL, Shiju TM, Santhiago MR, Wilson SE. Topical Losartan and Corticosteroid Additively Inhibit Corneal Stromal Myofibroblast Generation and Scarring Fibrosis After Alkali Burn Injury. Transl Vis Sci Technol. 2022 Jul 8;11(7):9. doi: 10.1167/tvst.11.7.9.
PubMed 35819289Brooke BS, Habashi JP, Judge DP, Patel N, Loeys B, Dietz HC 3rd. Angiotensin II blockade and aortic-root dilation in Marfan's syndrome. N Engl J Med. 2008 Jun 26;358(26):2787-95. doi: 10.1056/NEJMoa0706585.
PubMed 18579813Rosenkranz S. TGF-beta1 and angiotensin networking in cardiac remodeling. Cardiovasc Res. 2004 Aug 15;63(3):423-32. doi: 10.1016/j.cardiores.2004.04.030.
PubMed 15276467Gu L, Zhu Y, Lee M, Nguyen A, Ryujin NT, Huang JY, Pandit SK, Chamseddine S, Xiao L, Mohamed YI, Kaseb AO, Karin M, Shalapour S. Angiotensin II receptor inhibition ameliorates liver fibrosis and enhances hepatocellular carcinoma infiltration by effector T cells. Proc Natl Acad Sci U S A. 2023 May 9;120(19):e2300706120. doi: 10.1073/pnas.2300706120. Epub 2023 May 1.
PubMed 37126700
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Losartan as Treatment to Reduce Corneal Scarring Fibrosis
- ClinicalTrials.gov ID
- NCT07449000
- Acronym / sponsor ID
- OF25-00010
- Conditions
- Corneal Scarring Fibrosis
- Keywords
- Corneal scar, Corneal scarring, Corneal haze, Corneal opacity, Topical losartan
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 11 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Topical losartan | Active comparator | Drug: Topical losartanDrug: Topical Losartan 0.8 mg/ml ophthalmic Solution, one drop applied six times daily for six months |
| Placebo | Placebo comparator | Drug: Placebo ControlDrug: Balanced saline solution ophthalmic drops, one drop applied six times daily for six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical losartanDrug: Topical Losartan 0.8 mg/ml ophthalmic solution, one drop applied six times daily for six months. | Drug | Topical losartan |
| Placebo ControlDrug: Balanced saline solution ophthalmic drops, one drop applied six times daily for six months. | Drug | Placebo |
Primary outcome
Change in Best Corrected Visual Acuity (BCVA)
Time frame: Baseline to 6 months.
BCVA measured using ETDRS chart and reported in LogMAR units.
10 secondary outcomes
Change in Contrast Sensitivity
Time frame: Baseline to 6 months.
Change in Corneal Haze Severity
Time frame: Baseline to 6 months.
Change in Corneal Scar Density
Time frame: Baseline to 6 months
Change in Corneal Scar Area
Time frame: Baseline to 6 months.
Change in corneal aberrations
Time frame: Baseline to 6 months.
Change in Intraocular Pressure
Time frame: Baseline to 6 months.
Change in corneal pachymetry
Time frame: Baseline to 6 months.
Corneal scar depth
Time frame: Baseline to 6 months.
Treatment Adverse Events
Time frame: Baseline to 6 months.
Treatment Adherence
Time frame: Baseline to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- BackgroundCOZAAR® (losartan potassium) tablets, for oral use Initial U.S. Approval: 1995 . FDA
- BackgroundPLM. (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
- Background: PubMed 19571282Mauer M, Zinman B, Gardiner R, Suissa S, Sinaiko A, Strand T, Drummond K, Donnelly S, Goodyer P, Gubler MC, Klein R. Renal and retinal effects of enalapril and losartan in type 1 diabetes. N Engl J Med. 2009 Jul 2;361(1):40-51. doi: 10.1056/NEJMoa0808400.
- Background: PubMed 18800452Burnier M, Waeber B, Brunner HR. Clinical pharmacology of the angiotensin II receptor antagonist losartan potassium in healthy subjects. J Hypertens Suppl. 1995 Jul;13(1):S23-8. doi: 10.1097/00004872-199507001-00003.
- Background: PubMed 12859158Zandbergen AA, Baggen MG, Lamberts SW, Bootsma AH, de Zeeuw D, Ouwendijk RJ. Effect of losartan on microalbuminuria in normotensive patients with type 2 diabetes mellitus. A randomized clinical trial. Ann Intern Med. 2003 Jul 15;139(2):90-6. doi: 10.7326/0003-4819-139-2-200307150-00008.
- Background: PubMed 14652437Kubba S, Agarwal SK, Prakash A, Puri V, Babbar R, Anuradha S. Effect of losartan on albuminuria, peripheral and autonomic neuropathy in normotensive microalbuminuric type 2 diabetics. Neurol India. 2003 Sep;51(3):355-8.
- Background45. Pucker AD, Frogozo M, Malooley MM, Harthan JS. Point-Counter Point: Treating Corneal Haze with 0.8 mg/mL Topical Losartan. Clinical Insights in Eyecare. 2024;2(5).
- Background: PubMed 38573840Rodgers EG, Al-Mohtaseb Z, Chen AJ. Topical Losartan for Treating Corneal Haze After Ultraviolet-A/Riboflavin Collagen Cross-Linking. Cornea. 2024 Sep 1;43(9):1165-1170. doi: 10.1097/ICO.0000000000003527. Epub 2024 Mar 22.
- Background: PubMed 35074340Sampaio LP, Hilgert GSL, Shiju TM, Murillo SE, Santhiago MR, Wilson SE. Topical losartan inhibits corneal scarring fibrosis and collagen type IV deposition after Descemet's membrane-endothelial excision in rabbits. Exp Eye Res. 2022 Mar;216:108940. doi: 10.1016/j.exer.2022.108940. Epub 2022 Jan 21.
- Background: PubMed 37750746Sampaio LP, Villabona-Martinez V, Shiju TM, Santhiago MR, Wilson SE. Topical Losartan Decreases Myofibroblast Generation But Not Corneal Opacity After Surface Blast-Simulating Irregular PTK in Rabbits. Transl Vis Sci Technol. 2023 Sep 1;12(9):20. doi: 10.1167/tvst.12.9.20.
- Background: PubMed 36476304Sampaio LP, Hilgert GSL, Shiju TM, Santhiago MR, Wilson SE. Losartan Inhibition of Myofibroblast Generation and Late Haze (Scarring Fibrosis) After PRK in Rabbits. J Refract Surg. 2022 Dec;38(12):820-829. doi: 10.3928/1081597X-20221026-03. Epub 2022 Dec 1.
- Background: PubMed 35819289Sampaio LP, Hilgert GSL, Shiju TM, Santhiago MR, Wilson SE. Topical Losartan and Corticosteroid Additively Inhibit Corneal Stromal Myofibroblast Generation and Scarring Fibrosis After Alkali Burn Injury. Transl Vis Sci Technol. 2022 Jul 8;11(7):9. doi: 10.1167/tvst.11.7.9.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karim Mohamed-Noriega, Dr. med. principal investigator
Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical losartan in people with Corneal Scarring Fibrosis, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim Mohamed-Noriega, Dr. med. (+52 8113404960 ext. 8514, karim.mohamednrg@uanl.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best Corrected Visual Acuity (BCVA) (time frame: Baseline to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07449000, which also lists 46 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.