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

Safety and Efficacy of Sutureless Dehydrated Amniotic Membrane (Omnigen) Mounted on Contact Lens (Omnilenz) for Ttt of Ocular Graft vs Host Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07066865
Enrollment
3
Registered
2025-07-15
Start date
2022-04-01
Completion date
2024-04-01
Last updated
2025-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Graft Versus Host Disease

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.

Interventions

DEVICEomniLenz

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

Sponsors

Farwaniya Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Epithelial healing, Slit lamp examination with cobalt blue light after installation of fluorescein eye drops1 week ( duration of the application of omnilenz )

Secondary

MeasureTime frame
Omnigen tolerability, Questionnaire for the patients asking about discomfort sensation or the need to patch the eye1 week ( duration of the application of omnilenz )

Countries

Kuwait

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026