JRCT ID: jRCTs071220053
Registered date:14/09/2022
Clinical efficacy of FGLM-NH2+SSSR peptides eye drops for neurotrophic keratopathy in leprosy sequelae.
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | neurotorophic keratopathy |
Date of first enrollment | 28/10/2022 |
Target sample size | 12 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | In cases of neurotrophic keratopathy, FGLM-NH2+ SSSR instillation is instilled four times a day (mor ning, noon, evening, before bedtime). The amount of 1 time is 1 drop, and it continues for up to 3 months. In the case of the persistent corneal epith elial defect, the instillation can be discontinued if the epithelial defect disappears. Eye drops used at the start of the study can be used in combination as they are, but the contents of the instillation will not be changed during the research period. |
Outcome(s)
Primary Outcome | Improvement of neuroparalytic keratopathy The patient is judged to have improved when one or more of the following two criteria are met. -Healing and reducing epithelial defects -Changes in corneal thickness in thin corneas |
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Secondary Outcome | 1. visual acuity 2. subjectve findings 3. time to complete healing for persistent epithelial defect |
Key inclusion & exclusion criteria
Age minimum | >= 60age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Patients with neurotrophic keratopathy in leprosy sanatoriums 2. Cases with written consent by informed consent 3. Those with corneal perception of less than 40 m m nylon yarn length by the Cochet-Bonnet corneal perceptometer 4. Persistent corneal epithelial defects and/or Corneal stromal thinning |
Exclude criteria | 1. Hypersensitivity or history of eye drops 2. Those with treatment due to the infection in acute phase |
Related Information
Primary Sponsor | Kondo Shoko |
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Secondary Sponsor | |
Source(s) of Monetary Support | Ministry of Health, Labour and Welfare medical administration bureau leprosy sanatorium research fund will be acquired |
Secondary ID(s) |
Contact
Public contact | |
Name | Shoko Kondo |
Address | 3796 Sakae, Koshi-shi, Kumamoto Kumamoto Japan 861-1113 |
Telephone | +81-96-248-1131 |
shoko.kondo@gmail.com | |
Affiliation | National Sanatrium Kikuchi Keifuen |
Scientific contact | |
Name | Shoko Kondo |
Address | 3796 Sakae, Koshi-shi, Kumamoto Kumamoto Japan 861-1113 |
Telephone | +81-96-248-1131 |
shoko.kondo@gmail.com | |
Affiliation | National Sanatrium Kikuchi Keifuen |