An observational study in Neurotrophic Keratitis, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by University of California, Los Angeles · Observational
Neurotrophic keratopathy (NK) is a condition in which patients have fewer or complete absence of nerves in the cornea, characterized by the reduced or absent corneal sensation. The lack of nerves in the cornea also result in damages of the cornea and in severe situation the loss of the eye.
Cenegermin (trade name Oxervate) is a nerve growth factor eye drops designed to treat NK, and currently, it is the only FDA-approved medication for this purpose.
Even though cenegermin is effective in the majority of patients, there is a lack of understanding of how cenegermin works in the eye.
In this study, investigators aim to determine the structural and functional effects of cenegermin on the cornea, using non-invasive technologies including in vivo confocal microscopy on study participants with NK over the course of a year.
Cenegermin (OxervateTM) is a recombinant human form of nerve growth factor developed by Dompé Farmaceutici S.p.A. for patients who are diagnosed with corneal epithelial defects due to moderate to severe stages of NK.
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
This study's enrollment of 8 is below the median of 105 across 31 observational studies indexed under Keratitis.
Browse Keratitis studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who are 18 years of age or older, who have a persistent corneal epitheliopathy due to neurotrophic keratopathy that is refractory to conventional non-surgical treatments for 2 weeks or more, and who fulfill the inclusion and exclusion criteria detailed above.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with neurotrophic keratopathy.
Drug: Cenegermin Ophthalmic Solution [Oxervate]
An 8-week course of topical cenegermin eye drops given 6 times daily would be started in the affected eye, in conjunction with the pre-existing medical treatment for neurotrophic keratopathy. Patients will be followed-up at 4 weeks, 6 weeks, 8 weeks, 3 months, 6 months, 9 months and 12 months (±2 weeks at each time point) after treatment. At each visit, patients will be assessed to determine the corneal epithelial defect and corneal sensation.
Change in corneal nerve fiber density (CNFD)
To determine the changes in corneal nerve fiber density (CNFD), assessed by in vivo confocal microscopy.
Time frame: 1 year
Duration of changes in CNFD
To determine the duration of the changes in corneal nerve fiber density (CNFD), assessed by in vivo confocal microscopy.
Time frame: 1 year
Presence/absence of Changes in Dry Eye Symptom
To determine changes in dry eye symptom scores assessed by the Ocular Surface Disease Index in patients initiated on cenegermin for recalcitrant neurotrophic keratopathy. A score ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.
Time frame: 1 year
Changes in Tear Production
To determine the changes in tear production in patients initiated on cenegermin for recalcitrant neurotrophic keratopathy.
Time frame: 1 year
Changes in Tear Characteristics
To determine the changes in tear film osmolarity in patients initiated on cenegermin for recalcitrant neurotrophic keratopathy.
Time frame: 1 year
Plan to share: No
Ran from May 2022 to primary completion in Mar 2025, 34 months.
Of 16 observational studies under Keratitis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 34. This study's 34 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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