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

NCT ID: NCT07066865

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-04-01

Brief Summary

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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

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Conditions

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Ocular Graft Versus Host Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patient who applied OmniLenz for one week

Group Type EXPERIMENTAL

omniLenz

Intervention Type DEVICE

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

Interventions

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omniLenz

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Farwaniya Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nancy Lotfy, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Farwanyia Hospital

Al Farwānīyah, , Kuwait

Site Status

Countries

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Kuwait

Other Identifiers

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1630/2025

Identifier Type: -

Identifier Source: org_study_id

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