Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers
Topical Insulin in Treatment of Neurotrophic Corneal Ulcer,Efficacy And Safety
1 other identifier
interventional
14
0 countries
N/A
Brief Summary
To evaluate Safety and efficacy of topical insulin in treatment of neurotrophic corneal ulcers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2024
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2024
CompletedFirst Posted
Study publicly available on registry
March 26, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedMarch 26, 2024
March 1, 2024
1 year
March 15, 2024
March 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Decrease in ulcer size and the increase in visual acuity .
To evaluate the effect of topical insulin eye drops in treatment of neurotrophic corneal ulcer.
baseline
Study Arms (1)
insulin eye drop
EXPERIMENTALInterventions
Insulin eye drops deliver insulin directly to the cornea, They exploit insulin's ability to stimulate cell growth, potentially reducing healing time with minimal side effects.
Eligibility Criteria
You may qualify if:
- Patients with neurotrophic corneal ulcers caused by:
- Herpes simplex or Herpes zoster viral infection
- Topical anesthetics abuse
- Chemical and physical burn
- Chronic CL wear
- Following LASIK,PRK,CXL
- Following vitrectomy and endophotocoagulation for retinal detachment
- Diabetes mellitus
- Leprosy
- Trigeminal neuralgia surgery
You may not qualify if:
- Non compliant patients with the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Wang AL, Weinlander E, Metcalf BM, Barney NP, Gamm DM, Nehls SM, Struck MC. Use of Topical Insulin to Treat Refractory Neurotrophic Corneal Ulcers. Cornea. 2017 Nov;36(11):1426-1428. doi: 10.1097/ICO.0000000000001297.
PMID: 28742619BACKGROUNDShanley LJ, McCaig CD, Forrester JV, Zhao M. Insulin, not leptin, promotes in vitro cell migration to heal monolayer wounds in human corneal epithelium. Invest Ophthalmol Vis Sci. 2004 Apr;45(4):1088-94. doi: 10.1167/iovs.03-1064.
PMID: 15037573BACKGROUNDZagon IS, Klocek MS, Sassani JW, McLaughlin PJ. Use of topical insulin to normalize corneal epithelial healing in diabetes mellitus. Arch Ophthalmol. 2007 Aug;125(8):1082-8. doi: 10.1001/archopht.125.8.1082.
PMID: 17698755BACKGROUNDNishida T, Yanai R. Advances in treatment for neurotrophic keratopathy. Curr Opin Ophthalmol. 2009 Jul;20(4):276-81. doi: 10.1097/icu.0b013e32832b758f.
PMID: 19537364BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
March 15, 2024
First Posted
March 26, 2024
Study Start
April 1, 2024
Primary Completion
April 1, 2025
Study Completion
May 1, 2025
Last Updated
March 26, 2024
Record last verified: 2024-03