Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From… (NCT03845374) | Clinical Trial Compass
CompletedNot Applicable
Prospective, Randomized Multi-Center Study of Using the Hyper-CLâ„¢ Lens in Subjects Suffering From Bacterial Keratitis
Israel12 participantsStarted 2019-03-13
Plain-language summary
This study is a prospective, randomized, open-label, two arms, clinical study aim to evaluate the efficacy and safety of treatment with Hyper-CLâ„¢ lens + Antibiotics compared with treatment with Antibiotics only, in subjects with Bacterial keratitis.
The design of the Hyper-CLâ„¢ lens increases contact time of the antibiotics on the cornea enabling increased bioavailability of the active drug.
Who can participate
Age range18 Years – 86 Years
SexALL
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Inclusion criteria
✓. Subject is 18-86 years old
✓. Subject with Bacterial keratitis in one eye only
✓. Subject with Bacterial Keratitis of at least grade 2 score in Average length of infiltration and in Average length of epithelial defect (1mm or above)
✓. Best-corrected visual acuity of 6/60 or better in the uninvolved eye
✓. No prior antibiotic treatment for current Bacterial Keratitis
✓. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
Exclusion criteria
✕. Perforation or imminent perforation of cornea
✕. Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb
✕. Sign of inflammation in both eyes
✕. Severe itching suggesting viral infection or allergy reaction