A Phase 2/3 interventional study of OmniLenz® in Corneal Perforation, Exposure Keratitis and Infectious Keratitis, sponsored by Farwaniya Hospital. Completed at 1 site in Kuwait. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Farwaniya Hospital · Phase 2/3, Interventional, and Treatment
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.
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.
Farwaniya Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion/Exclusion Criteria:
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.
Combination Product: OmniLenz®
OmniLenz® applied for 1 week in all patients after development of corneal perforation
Size of corneal perforation
Size of corneal perforation will be measured in mm using slit lamp examination
Time frame: one week
size of epithelial defect
Size of epithelial defect will be measured in mm using slit lamp examination
Time frame: one week
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2022 to primary completion in Feb 2024, 22 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Corneal Perforation
Farwaniya Hospital