NCT07066865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
Last Updated

July 15, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

June 19, 2025

Last Update Submit

July 12, 2025

Conditions

Ocular Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

  • Epithelial healing, Slit lamp examination with cobalt blue light after installation of fluorescein eye drops

    1 week ( duration of the application of omnilenz )

Secondary Outcomes (1)

  • 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 )

Study Arms (1)

patient who applied OmniLenz for one week

EXPERIMENTAL
Device: omniLenz

Interventions

omniLenzDEVICE

sutureless dehydrated amniotic membrane (omnigen) mounted on contact lens (omnilenz)

patient who applied OmniLenz for one week

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Ocular graft versus host disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Farwanyia Hospital

Al Farwānīyah, Kuwait

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 19, 2025

First Posted

July 15, 2025

Study Start

April 1, 2022

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

July 15, 2025

Record last verified: 2025-06

Locations

KU(1)