NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedneurotorophic keratopathy
Date of first enrollment28/10/2022
Target sample size12
Countries of recruitment
Study typeInterventional
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 OutcomeImprovement 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
Secondary Outcome1. visual acuity 2. subjectve findings 3. time to complete healing for persistent epithelial defect

Key inclusion & exclusion criteria

Age minimum>= 60age old
Age maximumNot applicable
GenderBoth
Include criteria1. 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 criteria1. Hypersensitivity or history of eye drops 2. Those with treatment due to the infection in acute phase

Related Information

Contact

Public contact
Name Shoko Kondo
Address 3796 Sakae, Koshi-shi, Kumamoto Kumamoto Japan 861-1113
Telephone +81-96-248-1131
E-mail 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
E-mail shoko.kondo@gmail.com
Affiliation National Sanatrium Kikuchi Keifuen