To Evaluate the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial De… (NCT07120308) | Clinical Trial Compass
CompletedPhase 2
To Evaluate the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects Caused by Neurotrophic Keratitis
China28 participantsStarted 2021-09-15
Plain-language summary
An investigator-initiated single-center, randomized, double-blind, placebo-controlled clinical study .The main purpose is to evaluate the effectiveness of ZKY001 eye drops in treating corneal epithelial defects caused by neurotrophic keratitis in patients.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years ≤ aged ≤ 80 years; Consistent with the diagnosis of neurotrophic keratitis caused by diabetes or the herpes simplex virus; Patients with Stage 2 or Stage 3 neurotrophic keratitis,involving only one eye; PED or corneal ulceration of at least 2 weeks' duration refractory to one or more conventional non-surgical treatments for neurotrophic keratitis (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; medications that can decrease corneal sensitivity; therapeutic contact lenses and Cenegermin eye drops); Signed informed consent forms。
Exclusion Criteria:
* Patients with Stage 2 or 3 NK affecting both eyes; Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK in the affected eye; Any other ocular disease requiring topical ocular treatment in the affected eye during the study treatment period; Patients with severe vision loss in the affected eye with no potential for visual improvement in the opinion of the Investigator because of the study treatment; Schirmer's test without anesthesia ≤ 3 mm/ 5 minutes in the affected eye; Patients with severe blepharitis and/or severe meibomian gland disease in the affected eye; History of laser surgical procedures in the affected eye within the 3 months before study enrollment,history of any ocular surgery (except retinal laser photocoagulation) in the affected eye within the 1 month before study …
What they're measuring
1
Percentage of subjects with corneal epithelial healing(<0.5 mm lesion size) at D57.