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OpenTrials
Completed

NCT Number: NCT07066865

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

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.

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Key information

Conditions

Ocular Graft Versus Host Disease

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Farwanyia Hospital

Al Farwaniyah, Kuwait

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

omniLenz

Device

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

Primary outcomes

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

    Time frame: 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

    Time frame: 1 week ( duration of the application of omnilenz )

Sponsors and collaborators

Lead sponsor

Farwaniya Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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