Persistent Epithelial DefectNCT03653650
Autologous Platelet-rich Plasma in the Treatment of Persistent Epithelial Defects
A study testing PRP plus BCL, BCL plus PFL and Eye patch plus ocular lubricant ointment in people with Persistent Epithelial Defect, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
Persistent epithelial defects (PED) are corneal ulcers that do not heal within the first two weeks of treatment with artificial tears or ocular lubricant ointment. It is believed that this condition is the result of the loss of certain substances normally present in the tears that aid in the healing process of the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Persistent Epithelial Defect
- What is being tested?
- PRP plus BCL, BCL plus PFL and Eye patch plus ocular lubricant ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteMexico
- Study dates
- 30 Aug 2018to 1 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with persistent epithelial defect and at least one of the following diagnoses:
- Recurrent corneal epithelial defect.
- Neurotrophic corneal ulcer.
- Neurotrophic keratopathy secondary to any disease (i.e. diabetes mellitus, infection with herpes simplex virus or herpes zoster virus, microbial keratitis sequelae, multiple sclerosis, Parkinson's disease, VII cranial nerve palsy, chemical or thermic burn sequelae, trauma, surgery, iatrogenic, chronic dry eye, rheumatic disease).
Who cannot join
- Patients diagnosed with:
- Peripheral ulcerative keratitis, or Mooren's ulcer.
- Active infectious keratitis and/or ulcers.
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
Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460
Karim Mohamed-Noriega, M.D., +52 81 83469259, karim.mohamednrg@uanl.edu.mx
About this study
Official title: Autologous Platelet-rich Plasma in the Treatment of Persistent Corneal Epithelial Defects
Persistent epithelial defects (PED) are corneal ulcers that do not heal within the first two weeks of treatment with artificial tears or ocular lubricant ointment. It is believed that this condition is the result of the loss of certain substances normally present in the tears that aid in the healing process of the cornea. When the eye is healthy, these ulcers typically heal rapidly. However, when there is an underlying disease such as diabetes, this healing process is altered and it takes longer for the ulcer to heal. Autologous platelet-rich plasma (PRP) is a substance that is obtained from the patient's own blood and it is believed this substance may replace those missing factors in the tears of patients with PED. The purpose of this investigation is to find out whether PRP combined with a bandage contact lens is better than preservative free lubricant combined with bandage contact lens or than eye patch with ocular lubricant ointment for the treatment of PED. Participants will be randomly assigned to one of the three groups and will get the treatment until the ulcer heals completely. We will count the days it takes for the PED to heal and based on that we will determine wich treatment is more effective (the treatment that takes the least days to heal will be considered the most effective). Since this disease is difficult to treat and doesn't have a gold standard treatment, usually the available treatments are not as good as we would like, therefore, the ulcer might progress even to perforation regardless of the treatment. In these cases, we will provide appropriate treatment for progressive corneal thinning and corneal perforation.
Read the detailed description
Persistent epithelial defects (PED) are corneal lesions that do not heal within the first two weeks of conventional treatment (i.e. preservative-free lubricant, bandage contact lens (BCL), ocular lubricant ointment, eye patching). These defects are the result of the loss of certain lacrimal factors that maintain the integrity and homeostasis of the corneal epithelium and ocular surface. Normally, PED heal rapidly in the healthy eye. However, underlying ocular surface pathology can slow down the healing process and contribute to the persistence of the epithelial defect. Hematopoietic derivatives such as autologous platelet-rich plasma (PRP) may replace these missing components and eventually lead to complete healing in a faster and more comfortable way for the patient. The objective of this study is to determine if PRP combined with BCL is more effective than preservative-free lubricant combined with BCL or than eye patch with ocular lubricant ointment for the treatment of PED. Participants will be randomly assigned to one of the three groups and treatment will be administered until achieving complete defect closure. The effectiveness of each treatment will be measured in terms of days taken to achieve complete closure. Since PED is a complex disease that is difficult to treat, the available treatments are not very effective, therefore, PED might progress even to perforation regardless of the treatment. In this last scenario, we will provide appropriate treatment for progressive corneal thinning and corneal perforation
- Conditions
- Persistent Epithelial Defect
- Being tested
- PRP plus BCL, BCL plus PFL, Eye patch plus ocular lubricant ointment
- Keywords
- Platelet-Rich Plasma, Persistent Epithelial Defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP plus BCLCombination product
Bandage contact lens (BCL) plus 1 autologous platelet-rich plasma (PRP) eye drop every 1 to 3 hours.
BCL plus PFLCombination product
Bandage contact lens (BCL) plus 1 preservative-free lubricant (PFL) eye drop every 1 to 3 hours.
Eye patch plus ocular lubricant ointmentCombination product
Eye patch plus ocular lubricant ointment every 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| PRP plus BCL | Experimental | Bandage contact lens (BCL) plus 1 autologous platelet-rich plasma (PRP) eye drop every 1 to 3 hours. Receives: Combination Product: PRP plus BCL |
| BCL plus PFL | Active comparator | Bandage contact lens (BCL) plus 1 preservative-free lubricant (PFL) eye drop every 1 to 3 hours. Receives: Combination Product: BCL plus PFL |
| Eye patch plus ocular lubricant ointment | Active comparator | Eye patch plus ocular lubricant ointment every 24 hours. Receives: Combination Product: Eye patch plus ocular lubricant ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent epithelial defect healing time.
Persistent epithelial defect healing time measured in days.
Measured: From the first day of treatment until the date of complete defect closure, assessed up to 3 months.
Secondary outcomes (8)
Change in corneal sensitivity
Corneal sensitivity will be assessed with corneal esthesiometer Cochet-Bonnet.
Measured: Change from baseline corneal sensitivity at the date of defect closure, up to 3 months.
Uncorrected visual acuity
Uncorrected visual acuity will be assessed using Snellen cards. Measurements will be converted to LogMar values for statistical analysis.
Measured: Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Best corrected visual acuity
Best corrected visual acuity will be assessed using Snellen cards. Measurements will be converted to LogMar values for statistical analysis.
Measured: Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Ocular pain
Ocular pain will be assessed using the Wong-Baker Faces Pain Rating Scale. The scale ranges from 0 (no pain) to 10 (maximum pain), and includes 6 faces (visual representation), numbers, and written descriptions that represent the level of pain. The first face represents a pain score of 0 and it reads "no hurt"; the second face represents a pain score of 2 and it reads "hurts little bit"; the third face represents a pain score of 4 and it reads "hurts little more"; the fourth face represents a pain score of 6 and it reads "hurts even more"; the fifth face represents a pain score of 8 and it reads "hurts whole lot"; the last face represents a pain score of 10 and it reads "hurst worst". Lower values represent a better outcome.
Measured: Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Ocular surface symptoms
Ocular surface symptoms as assessed by the Symptom Assessment in Dry Eye (SANDE) questionnaire. The SANDE questionnaire consists of two questions presented in visual analog scale. The first question assesses the frequency of dry eye syndrome and the scale ranges from "rarely" to "all the time" on a 100 mm line. The second question assesses the severity of dry eye syndrome and the scale ranges from "very mild" to "very severe" on a 100 mm line. Patients are asked to place a mark on the line to represent the extent of their symptoms, then the location of the marks on each line are measured from left to right in mm. The SANDE score is calculated by multiplying the frequency value times the severity value and obtaining the square root. Lower scores represent a better outcome.
Measured: Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Ocular surface symptoms
Ocular surface symptoms as assessed by the Ocular Surface Disease Index (OSDI). The OSDI questionnaire consists of 12 questions that assess dry eye symptoms and their effects on vision related function. The questionnaire is divided in 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients are asked to rate their responses on a 0 to 4 scale where 0 represents "none of the time", 1 "some of the time", 2 "half of the time", 3 "most of the time", and 4 "all of the time". The total score is calculated using the following formula: ([sum of scores for all questions answered x 100] / [total number of questions answered x 4]). Lower scores represent a better outcome.
Measured: At date of randomization and at date of defect closure, up to 3 months.
Quality of life questionnaire
Quality of life as assessed by the National Eye Institute Visual Function Questionnaire (NEI VFQ-25). The NEI VFQ-25 questionnaire consists of 25 questions that assess the effect of visual impairment on the patient's quality of life. The 25-item questionnaire gives a score on a scale of 0 to 100, where 0 is the worst score and 100 is the best score. Higher scores represent a better outcome.
Measured: At date of randomization and at date of defect closure, up to 3 months.
Frequency of adverse events, recurrences and/or treatment failure
Frequency of adverse events, recurrences and/or treatment failure will be evaluated during the ophthalmic evaluation.
Measured: These will be evaluated from the beginning of the treatment until three months after defect closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start30 Aug 2018
- Primary completionAug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Persistent Epithelial DefectStudies 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
- Subjects will be randomly assigned to three groups. Demographic characteristics and underlying etiologies will be identified. Subjects will undergo a general ophthalmologic evaluation (baseline) and PED size will be measured. Treatments will be administered until complete defect healing is achieved and visits will be scheduled weekly or as needed for continued ophthalmologic evaluation. After complete closure, subjects will be followed for three months with visits every 2 to 4 weeks to evaluate progress and identify recurrences.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Responsible party
- Principal investigator, Karim Mohamed-Noriega, Universidad Autonoma de Nuevo Leon
- Investigators
- Karim Mohamed-Noriega, M.D., Principal investigator, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653650
- Sponsor's protocol ID
- OF18-00003
- Status last verified
- May 2026
- First submitted
- 16 Aug 2018
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsubota K, Goto E, Shimmura S, Shimazaki J. Treatment of persistent corneal epithelial defect by autologous serum application. Ophthalmology. 1999 Oct;106(10):1984-9. doi: 10.1016/S0161-6420(99)90412-8.
PubMed 10519596Chen J, Chen P, Backman LJ, Zhou Q, Danielson P. Ciliary Neurotrophic Factor Promotes the Migration of Corneal Epithelial Stem/progenitor Cells by Up-regulation of MMPs through the Phosphorylation of Akt. Sci Rep. 2016 May 13;6:25870. doi: 10.1038/srep25870.
PubMed 27174608Ljubimov AV, Saghizadeh M. Progress in corneal wound healing. Prog Retin Eye Res. 2015 Nov;49:17-45. doi: 10.1016/j.preteyeres.2015.07.002. Epub 2015 Jul 18.
PubMed 26197361Nugent RB, Lee GA. Ophthalmic use of blood-derived products. Surv Ophthalmol. 2015 Sep-Oct;60(5):406-34. doi: 10.1016/j.survophthal.2015.03.003. Epub 2015 Apr 15.
PubMed 26077627Alio JL, Rodriguez AE, WrobelDudzinska D. Eye platelet-rich plasma in the treatment of ocular surface disorders. Curr Opin Ophthalmol. 2015 Jul;26(4):325-32. doi: 10.1097/ICU.0000000000000169.
PubMed 26058033Alio JL, Abad M, Artola A, Rodriguez-Prats JL, Pastor S, Ruiz-Colecha J. Use of autologous platelet-rich plasma in the treatment of dormant corneal ulcers. Ophthalmology. 2007 Jul;114(7):1286-1293.e1. doi: 10.1016/j.ophtha.2006.10.044. Epub 2007 Feb 26.
PubMed 17324465Kim KM, Shin YT, Kim HK. Effect of autologous platelet-rich plasma on persistent corneal epithelial defect after infectious keratitis. Jpn J Ophthalmol. 2012 Nov;56(6):544-50. doi: 10.1007/s10384-012-0175-y. Epub 2012 Sep 13.
PubMed 22972393
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Platelet-rich Plasma in the Treatment of Persistent Corneal Epithelial Defects
- ClinicalTrials.gov ID
- NCT03653650
- Acronym / sponsor ID
- OF18-00003
- Conditions
- Persistent Epithelial Defect
- Keywords
- Platelet-Rich Plasma, Persistent Epithelial Defect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 31 Aug 2018 (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.
Persistent epithelial defects (PED) are corneal ulcers that do not heal within the first two weeks of treatment with artificial tears or ocular lubricant ointment. It is believed that this condition is the result of the loss of certain substances normally present in the tears that aid in the healing process of the cornea. When the eye is healthy, these ulcers typically heal rapidly. However, when there is an underlying disease such as diabetes, this healing process is altered and it takes longer for the ulcer to heal. Autologous platelet-rich plasma (PRP) is a substance that is obtained from the patient's own blood and it is believed this substance may replace those missing factors in the tears of patients with PED. The purpose of this investigation is to find out whether PRP combined with a bandage contact lens is better than preservative free lubricant combined with bandage contact lens or than eye patch with ocular lubricant ointment for the treatment of PED. Participants will be randomly assigned to one of the three groups and will get the treatment until the ulcer heals completely. We will count the days it takes for the PED to heal and based on that we will determine wich treatment is more effective (the treatment that takes the least days to heal will be considered the most effective). Since this disease is difficult to treat and doesn't have a gold standard treatment, usually the available treatments are not as good as we would like, therefore, the ulcer might progress even to perforation regardless of the treatment. In these cases, we will provide appropriate treatment for progressive corneal thinning and corneal perforation.
Detailed description
Persistent epithelial defects (PED) are corneal lesions that do not heal within the first two weeks of conventional treatment (i.e. preservative-free lubricant, bandage contact lens (BCL), ocular lubricant ointment, eye patching). These defects are the result of the loss of certain lacrimal factors that maintain the integrity and homeostasis of the corneal epithelium and ocular surface. Normally, PED heal rapidly in the healthy eye. However, underlying ocular surface pathology can slow down the healing process and contribute to the persistence of the epithelial defect. Hematopoietic derivatives such as autologous platelet-rich plasma (PRP) may replace these missing components and eventually lead to complete healing in a faster and more comfortable way for the patient. The objective of this study is to determine if PRP combined with BCL is more effective than preservative-free lubricant combined with BCL or than eye patch with ocular lubricant ointment for the treatment of PED. Participants will be randomly assigned to one of the three groups and treatment will be administered until achieving complete defect closure. The effectiveness of each treatment will be measured in terms of days taken to achieve complete closure. Since PED is a complex disease that is difficult to treat, the available treatments are not very effective, therefore, PED might progress even to perforation regardless of the treatment. In this last scenario, we will provide appropriate treatment for progressive corneal thinning and corneal perforation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects will be randomly assigned to three groups. Demographic characteristics and underlying etiologies will be identified. Subjects will undergo a general ophthalmologic evaluation (baseline) and PED size will be measured. Treatments will be administered until complete defect healing is achieved and visits will be scheduled weekly or as needed for continued ophthalmologic evaluation. After complete closure, subjects will be followed for three months with visits every 2 to 4 weeks to evaluate progress and identify recurrences.
| Arm | Type | Receives |
|---|---|---|
| PRP plus BCL | Experimental | Combination Product: PRP plus BCLBandage contact lens (BCL) plus 1 autologous platelet-rich plasma (PRP) eye drop every 1 to 3 hours. |
| BCL plus PFL | Active comparator | Combination Product: BCL plus PFLBandage contact lens (BCL) plus 1 preservative-free lubricant (PFL) eye drop every 1 to 3 hours. |
| Eye patch plus ocular lubricant ointment | Active comparator | Combination Product: Eye patch plus ocular lubricant ointmentEye patch plus ocular lubricant ointment every 24 hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with persistent epithelial defect and at least one of the following diagnoses:
Key exclusion criteria (3 listed)
- Patients diagnosed with:
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 |
|---|---|---|
| PRP plus BCLBandage contact lens (BCL) plus 1 autologous platelet-rich plasma (PRP) eye drop every 1 to 3 hours. | Combination product | PRP plus BCL |
| BCL plus PFLBandage contact lens (BCL) plus 1 preservative-free lubricant (PFL) eye drop every 1 to 3 hours. | Combination product | BCL plus PFL |
| Eye patch plus ocular lubricant ointmentEye patch plus ocular lubricant ointment every 24 hours. | Combination product | Eye patch plus ocular lubricant ointment |
Primary outcome
Persistent epithelial defect healing time.
Time frame: From the first day of treatment until the date of complete defect closure, assessed up to 3 months.
Persistent epithelial defect healing time measured in days.
8 secondary outcomes
Change in corneal sensitivity
Time frame: Change from baseline corneal sensitivity at the date of defect closure, up to 3 months.
Uncorrected visual acuity
Time frame: Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Best corrected visual acuity
Time frame: Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Ocular pain
Time frame: Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Ocular surface symptoms
Time frame: Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Ocular surface symptoms
Time frame: At date of randomization and at date of defect closure, up to 3 months.
Quality of life questionnaire
Time frame: At date of randomization and at date of defect closure, up to 3 months.
Frequency of adverse events, recurrences and/or treatment failure
Time frame: These will be evaluated from the beginning of the treatment until three months after defect closure.
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 6 May 2026.
- Background: PubMed 10519596Tsubota K, Goto E, Shimmura S, Shimazaki J. Treatment of persistent corneal epithelial defect by autologous serum application. Ophthalmology. 1999 Oct;106(10):1984-9. doi: 10.1016/S0161-6420(99)90412-8.
- Background: PubMed 27174608Chen J, Chen P, Backman LJ, Zhou Q, Danielson P. Ciliary Neurotrophic Factor Promotes the Migration of Corneal Epithelial Stem/progenitor Cells by Up-regulation of MMPs through the Phosphorylation of Akt. Sci Rep. 2016 May 13;6:25870. doi: 10.1038/srep25870.
- Background: PubMed 26197361Ljubimov AV, Saghizadeh M. Progress in corneal wound healing. Prog Retin Eye Res. 2015 Nov;49:17-45. doi: 10.1016/j.preteyeres.2015.07.002. Epub 2015 Jul 18.
- Background: PubMed 26077627Nugent RB, Lee GA. Ophthalmic use of blood-derived products. Surv Ophthalmol. 2015 Sep-Oct;60(5):406-34. doi: 10.1016/j.survophthal.2015.03.003. Epub 2015 Apr 15.
- Background: PubMed 26058033Alio JL, Rodriguez AE, WrobelDudzinska D. Eye platelet-rich plasma in the treatment of ocular surface disorders. Curr Opin Ophthalmol. 2015 Jul;26(4):325-32. doi: 10.1097/ICU.0000000000000169.
- Background: PubMed 17324465Alio JL, Abad M, Artola A, Rodriguez-Prats JL, Pastor S, Ruiz-Colecha J. Use of autologous platelet-rich plasma in the treatment of dormant corneal ulcers. Ophthalmology. 2007 Jul;114(7):1286-1293.e1. doi: 10.1016/j.ophtha.2006.10.044. Epub 2007 Feb 26.
- Background: PubMed 22972393Kim KM, Shin YT, Kim HK. Effect of autologous platelet-rich plasma on persistent corneal epithelial defect after infectious keratitis. Jpn J Ophthalmol. 2012 Nov;56(6):544-50. doi: 10.1007/s10384-012-0175-y. Epub 2012 Sep 13.
- Individual participant dataSharing planned: No
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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, M.D. principal investigator
Hospital Universitario Dr. Jose E. Gonzalez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP plus BCL, BCL plus PFL and Eye patch plus ocular lubricant ointment in people with Persistent Epithelial Defect, 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 4 inclusion and 3 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 6 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. 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, M.D. (+52 8183469259, 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?
Persistent epithelial defect healing time. (time frame: From the first day of treatment until the date of complete defect closure, assessed up to 3 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 NCT03653650, which also lists 7 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 6 May 2026.