Clinical efficacy of FGLM-NH2+SSSR peptides eye drops for neurotrophic keratopathy in leprosy sequelae.

Not Applicable

• Conditions: neurotorophic keratopathy; neurotrophic keratopathy, persistent epitherial defect, corneal stromal thinning

• Registration Number: JPRN-jRCTs071220053
• Lead Sponsor: Kondo Shoko

Brief Summary

12 eyes of 11 patients with neurotrophic keratopathy due to sequelae of leprosy were treated with FGLM-NH2+SSSR peptides ophthalmic solution for up to 12 weeks. Improvement in the primary endpoint of neurotrophic keratopathy was judged to have improved in 83.3% of 12 patients (90% confidence interval p < 0.00001). FGLM-NH2+SSSR eye drops are considered to be effective for neurotrophic keratopathy, which is a sequelae of leprosy, and its ordinary use is strongly desired.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-14
• Study Completion: 2023-04-30
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion 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

Exclusion Criteria

1. Hypersensitivity or history of eye drops
2. Those with treatment due to the infection in acute phase

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of neuroparalytic keratopathy<br>The patient is judged to have improved when one or more of the following two criteria are met.<br><br>-Healing and reducing epithelial defects<br>-Changes in corneal thickness in thin corneas

Secondary Outcome Measures

Name	Time	Method
1. visual acuity<br>2. subjectve findings<br>3. time to complete healing for persistent epithelial defect