The Role of OmniLenz® in the Treatment of Small Corneal Perforations Secondary to Exposure Keratitis in ICU Patients

NCT06539663 | Completed Phase 2 DMC

• 1 other identifier: 2024-632-4385
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Case series of 5 ICU patients in Farwaniya Hospital who developed exposure keratitis and a subsequent small corneal perforation between April 2022 and April 2024. The investigators highlight the non-surgical role of OmniLenz® in the treatment of small corneal perforations secondary to exposure keratitis. The inclusion criteria were corneal perforation less than 1mm in size, positive culture \& sensitivity results and showing initial improvement on topical antibiotic eye drops.

Conditions

Corneal Perforation; Exposure Keratitis; Infectious Keratitis

Outcome Measures

Primary Outcomes (1)

• Size of corneal perforation

  Size of corneal perforation will be measured in mm using slit lamp examination

  one week

Secondary Outcomes (1)

• size of epithelial defect

  one week

Study Arms (1)

Treatment of Corneal Perforation

EXPERIMENTAL

All patients were prescribed Fortified Vancomycin (50mg %) and Fortified Fortum (50mg %) antibiotic eye drops for initial exposure keratitis with corneal infiltration. Then treatment was modified according to culture and sensitivity results. Subsequent corneal perforation developed for which OmniLenz® was applied in all patients for 1 week.

Combination Product: OmniLenz®

Interventions

OmniLenz® COMBINATION_PRODUCT

OmniLenz® applied for 1 week in all patients after development of corneal perforation

Treatment of Corneal Perforation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with small corneal perforations measuring \< 1 mm in diameter. Those with larger perforations (\>1mm) were excluded.
• Patients with conclusive results of keratitis (confirmed via culture and sensitivity scraping) AND showing improved keratitis following antibiotic treatment. Those with no confirmed keratitis through C\&S or with inconclusive scraping results were excluded.
• No age or gender restrictions were applied.

Sponsors & Collaborators

• Farwaniya Hospital: lead

Study Sites (1)

Farwaniya Hospital

Kuwait City, 81004, PO Box 13372, Kuwait

Location

MeSH Terms

Conditions

Corneal Perforation

Condition Hierarchy (Ancestors)

Corneal Injuries; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Eye Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 6, 2024
• Study Start: April 10, 2022
• Primary Completion: February 10, 2024
• Study Completion: April 10, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)