Acute Chemical Eye InjuriesOmnigenNCT05618522
Omnigen in Acute Chemical Eye Injuries
A study testing vacuum-dehydrated amnion membrane (omnigen) and the lens loaded with Omnigen in people with Acute Chemical Eye Injuries, run by Farwaniya Hospital at 1 site in Kuwait.
Trial summary
evaluation of the role of Omnigen in acute chemical eye injuries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Chemical Eye Injuries
- What is being tested?
- vacuum-dehydrated amnion membrane (omnigen) and the lens loaded with Omnigen
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Jul 2021to 1 Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute chemical eye injury
Who cannot join
- absent or shallow fornices
- symblepharon interfering with lens placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Low Temperature Vacuum-dehydrated Amnion Membrane (Omnigen) in Treatment of Acute Chemical Eye Injuries
evaluation of the role of Omnigen in acute chemical eye injuries
Read the detailed description
prospective interventional study included patients with different degrees of acute chemical eye injuries were treated by Omnigen and followed up for one month
- Conditions
- Acute Chemical Eye Injuries
- Being tested
- vacuum-dehydrated amnion membrane (omnigen), the lens loaded with Omnigen
- Keywords
- amniotic membrane, chemical eye injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vacuum-dehydrated amnion membrane (omnigen)Procedure or surgery
Also called application of amnilenz
applying the lens loaded with Omnigen on the cornea
the lens loaded with OmnigenDevice
the lens loaded with Omnigen
| Study group | Role | What they receive |
|---|---|---|
| the lens loaded with Omnigen | Other | patients with acute chemical eye injury treated with omnigen Receives: Procedure: vacuum-dehydrated amnion membrane (omnigen); Device: the lens loaded with Omnigen |
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 installing fluroscein drops
Measured: 1 week
limbal ischaemia
slit lamp examination of the clock hours of vascularity around the limbususing both Due classification and Roper Hall
Measured: 1 week
Secondary outcomes (1)
omnigen tolerability
questionnaire for the patients asking about discomfort sensation or the need to patch the eye
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Jul 2021
- Primary completion1 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Chemical Eye InjuriesStudies 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
- Model description
- prospective
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farwaniya Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nancy Maher, Farwaniya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618522
- Sponsor's protocol ID
- Omnigen
- Other IDs
- associate professor
- Acronym
- Omnigen
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Low Temperature Vacuum-dehydrated Amnion Membrane (Omnigen) in Treatment of Acute Chemical Eye Injuries
- ClinicalTrials.gov ID
- NCT05618522
- Acronym / sponsor ID
- Omnigen / Omnigen
- Conditions
- Acute Chemical Eye Injuries
- Keywords
- amniotic membrane, chemical eye injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Farwaniya HospitalOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 16 Nov 2022 (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.
evaluation of the role of Omnigen in acute chemical eye injuries
Detailed description
prospective interventional study included patients with different degrees of acute chemical eye injuries were treated by Omnigen and followed up for one month
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective
| Arm | Type | Receives |
|---|---|---|
| the lens loaded with Omnigen | Other | Procedure: vacuum-dehydrated amnion membrane (omnigen), Device: the lens loaded with Omnigenpatients with acute chemical eye injury treated with omnigen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute chemical eye injury
Key exclusion criteria (2 listed)
- absent or shallow fornices
- symblepharon interfering with lens placement
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 |
|---|---|---|
| vacuum-dehydrated amnion membrane (omnigen)Also: application of amnilenzapplying the lens loaded with Omnigen on the cornea | Procedure or surgery | the lens loaded with Omnigen |
| the lens loaded with Omnigenthe lens loaded with Omnigen | Device | the lens loaded with Omnigen |
Primary outcome
Epithelial healing
Time frame: 1 week
slit lamp examination with cobalt blue light after installing fluroscein drops
limbal ischaemia
Time frame: 1 week
slit lamp examination of the clock hours of vascularity around the limbususing both Due classification and Roper Hall
1 secondary outcome
omnigen tolerability
Time frame: 1 week
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 16 Nov 2022.
- Individual participant dataSharing planned: No
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 vacuum-dehydrated amnion membrane (omnigen) and the lens loaded with Omnigen in people with Acute Chemical Eye Injuries, 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 2 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 16 Nov 2022. 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 (time frame: 1 week). The study lists 2 primary outcomes in all. 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 16 Nov 2022.