Evaluation of the Safety and Effectiveness of omniLenz in Patient With Ocular Graft vs Host Disease

Not Applicable

Completed

• Conditions: Ocular Graft Versus Host Disease

• Registration Number: NCT07066865
• Lead Sponsor: Farwaniya Hospital

Brief Summary

A case series of patients presented with graft versus host disease with ocular involvement . The study recruited a total of 3 patients who were referred to cornea clinic of Farwaniya Hospital, Kuwait between April 2022 and April 2024. All cases presented with severe dryness, spks and corneal epithelial defect not responding to other measures of treatment. An OmniLenz was applied for each patient for one week. Primary outcome measures included healing of the corneal resistant epithelial defect, secondary outcome measures were improvement of signs of dryness.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-07-12
• Last Update Submitted: 2025-07-12
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Clinical diagnosis of Ocular graft versus host disease

Exclusion Criteria

• Patient with conjunctival fibrosis and symblephara formation (which interfere with application of the omnilenz)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Epithelial healing, Slit lamp examination with cobalt blue light after installation of fluorescein eye drops	1 week ( duration of the application of omnilenz )

Secondary Outcome Measures

Name	Time	Method
Omnigen tolerability, Questionnaire for the patients asking about discomfort sensation or the need to patch the eye	1 week ( duration of the application of omnilenz )

Trial Locations

Locations (1)

Farwanyia Hospital; 🇰🇼 Al Farwānīyah, Kuwait