Evaluation of the Safety and Effectiveness of omniLenz in... | NCT07066865

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

NCT07066865

Sponsor

Farwaniya Hospital

Status

Completed

Last Update Posted

Jul 15, 2025Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Ocular Graft Versus Host Disease

Interventions

omniLenz

Countries

Kuwait

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

Apr 1, 2024Actual

Completion Date

Apr 1, 2024Actual

First Submitted Date

Jun 19, 2025

First Submission Date that Met QC Criteria

Jul 12, 2025

First Posted Date

Jul 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2025

Last Update Posted Date

Jul 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient who applied OmniLenz for one week	Experimental		Device: omniLenz

Interventions

Name	Type	Description	Arm Group Labels	Other Names
omniLenz	Device	sutureless dehydrated amniotic membrane (omnigen) mounted on contact lens (omnilenz)	patient who applied OmniLenz for one week

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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 )

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Farwanyia Hospital		Al Farwaniyah			Kuwait