Corneal PerforationPhase 2/3NCT06539663
The Role of OmniLenz® in the Treatment of Small Corneal Perforations Secondary to Exposure Keratitis in ICU Patients
A Phase 2/3 study testing OmniLenz® in people with Corneal Perforation and Exposure Keratitis, run by Farwaniya Hospital at 1 site in Kuwait.
Trial summary
Case series of 5 ICU patients in Farwaniya Hospital who developed exposure keratitis and a subsequent small corneal perforation between April 2022 and April 2024. The investigators highlight the non-surgical role of OmniLenz® in the treatment of small corneal perforations secondary to exposure keratitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Perforation, Exposure Keratitis, Infectious Keratitis
- What is being tested?
- OmniLenz®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteKuwait
- Study dates
- 10 Apr 2022to 10 Apr 2024
- Phase
- Phase 2/3
- 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
- Patients with small corneal perforations measuring < 1 mm in diameter. Those with larger perforations (>1mm) were excluded.
- Patients with conclusive results of keratitis (confirmed via culture and sensitivity scraping) AND showing improved keratitis following antibiotic treatment. Those with no confirmed keratitis through C\&S or with inconclusive scraping results were excluded.
- No age or gender restrictions were applied.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Case series of 5 ICU patients in Farwaniya Hospital who developed exposure keratitis and a subsequent small corneal perforation between April 2022 and April 2024.
The investigators highlight the non-surgical role of OmniLenz® in the treatment of small corneal perforations secondary to exposure keratitis. The inclusion criteria were corneal perforation less than 1mm in size, positive culture \& sensitivity results and showing initial improvement on topical antibiotic eye drops.
Read the detailed description
The primary outcome measures were healing of the corneal perforation, a negative Seidel test and reformation of the anterior chamber.
Secondary outcome measures were improvement of all three of ciliary injection, state of epithelial defect, and corneal infiltration.
- Being tested
- OmniLenz®
- Medical subject headings
- Corneal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmniLenz®Combination product
OmniLenz® applied for 1 week in all patients after development of corneal perforation
| Study group | Role | What they receive |
|---|---|---|
| Treatment of Corneal Perforation | Experimental | All patients were prescribed Fortified Vancomycin (50mg %) and Fortified Fortum (50mg %) antibiotic eye drops for initial exposure keratitis with corneal infiltration. Then treatment was modified according to culture and sensitivity results.
Subsequent corneal perforation developed for which OmniLenz® was applied in all patients for 1 week. Receives: Combination Product: OmniLenz® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of corneal perforation
Size of corneal perforation will be measured in mm using slit lamp examination
Measured: one week
Secondary outcomes (1)
size of epithelial defect
Size of epithelial defect will be measured in mm using slit lamp examination
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start10 Apr 2022
- Primary completion10 Feb 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal PerforationStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farwaniya Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nancy Lotfy, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539663
- Sponsor's protocol ID
- 2024-632-4385
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 6 Aug 2024
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of OmniLenz® in the Treatment of Small Corneal Perforations Secondary to Exposure Keratitis in ICU Patients
- ClinicalTrials.gov ID
- NCT06539663
- Acronym / sponsor ID
- 2024-632-4385
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Farwaniya HospitalOther government
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 6 Aug 2024 (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.
Case series of 5 ICU patients in Farwaniya Hospital who developed exposure keratitis and a subsequent small corneal perforation between April 2022 and April 2024.
The investigators highlight the non-surgical role of OmniLenz® in the treatment of small corneal perforations secondary to exposure keratitis. The inclusion criteria were corneal perforation less than 1mm in size, positive culture \& sensitivity results and showing initial improvement on topical antibiotic eye drops.
Detailed description
The primary outcome measures were healing of the corneal perforation, a negative Seidel test and reformation of the anterior chamber.
Secondary outcome measures were improvement of all three of ciliary injection, state of epithelial defect, and corneal infiltration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of Corneal Perforation | Experimental | Combination Product: OmniLenz®All patients were prescribed Fortified Vancomycin (50mg %) and Fortified Fortum (50mg %) antibiotic eye drops for initial exposure keratitis with corneal infiltration. Then treatment was modified according to culture and sensitivity results. Subsequent corneal perforation developed for which OmniLenz® was applied in all patients for 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with small corneal perforations measuring < 1 mm in diameter. Those with larger perforations (>1mm) were excluded.
- Patients with conclusive results of keratitis (confirmed via culture and sensitivity scraping) AND showing improved keratitis following antibiotic treatment. Those with no confirmed keratitis through C\&S or with inconclusive scraping results were excluded.
- No age or gender restrictions were applied.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OmniLenz®OmniLenz® applied for 1 week in all patients after development of corneal perforation | Combination product | Treatment of Corneal Perforation |
Primary outcome
Size of corneal perforation
Time frame: one week
Size of corneal perforation will be measured in mm using slit lamp examination
1 secondary outcome
size of epithelial defect
Time frame: one 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 6 Aug 2024.
- 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 Phase 2/3 study testing OmniLenz® in people with Corneal Perforation and Exposure Keratitis, 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 3 inclusion and 0 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 6 Aug 2024. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Size of corneal perforation (time frame: one week). 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 6 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.