Ocular Graft Versus Host DiseaseNCT07066865
Evaluation of the Safety and Effectiveness of omniLenz in Patient With Ocular Graft vs Host Disease
A study testing omniLenz in people with Ocular Graft Versus Host Disease, run by Farwaniya Hospital at 1 site in Kuwait.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ocular Graft Versus Host Disease
- What is being tested?
- omniLenz
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Apr 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Ocular graft versus host disease
Who cannot join
- Patient with conjunctival fibrosis and symblephara formation (which interfere with application of the omnilenz)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Sutureless Dehydrated Amniotic Membrane (Omnigen) Mounted on Contact Lens (Omnilenz) for Ttt of 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.
- Conditions
- Ocular Graft Versus Host Disease
- Being tested
- omniLenz
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omniLenzDevice
sutureless dehydrated amniotic membrane (omnigen) mounted on contact lens (omnilenz)
| Study group | Role | What they receive |
|---|---|---|
| patient who applied OmniLenz for one week | Experimental | Not described Receives: Device: omniLenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelial healing, Slit lamp examination with cobalt blue light after installation of fluorescein eye drops
Measured: 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
Measured: 1 week ( duration of the application of omnilenz )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Apr 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farwaniya Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nancy Lotfy, MD, Farwaniya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066865
- Sponsor's protocol ID
- 1630/2025
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sutureless Dehydrated Amniotic Membrane (Omnigen) Mounted on Contact Lens (Omnilenz) for Ttt of Ocular Graft vs Host Disease
- ClinicalTrials.gov ID
- NCT07066865
- Acronym / sponsor ID
- 1630/2025
- Conditions
- Ocular Graft Versus Host Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Farwaniya HospitalOther government
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient who applied OmniLenz for one week | Experimental | Device: omniLenz |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Ocular graft versus host disease
Key exclusion criteria (1 listed)
- Patient with conjunctival fibrosis and symblephara formation (which interfere with application of the omnilenz)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omniLenzsutureless dehydrated amniotic membrane (omnigen) mounted on contact lens (omnilenz) | Device | patient who applied OmniLenz for one week |
Primary outcome
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 )
1 secondary outcome
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 )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omniLenz in people with Ocular Graft Versus Host Disease, run by Farwaniya Hospital at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.