Bacterial Keratitis
Conditions
Brief summary
This study is a prospective, randomized, open-label, two arms, clinical study aim to evaluate the efficacy and safety of treatment with Hyper-CL™ lens + Antibiotics compared with treatment with Antibiotics only, in subjects with Bacterial keratitis. The design of the Hyper-CL™ lens increases contact time of the antibiotics on the cornea enabling increased bioavailability of the active drug.
Detailed description
The Hyper-CL™ Therapeutic soft contact lenses for short-term wear (up to 7 days) are indicated for therapeutic use to promote corneal healing and relieve corneal pain by protecting the cornea during the treatment of acute or chronic pathologies, such as corneal edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery.
Interventions
DEVICEHyper-CL™ lens
Use of the Hyper-CL™
Sponsors
Eye-yon Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
40 patients will be randomized to one of the following 2 groups: * Treatment Group 1: Conventional treatment of topical Antibiotics+ Hyper-CL lens * Treatment Group 2: Conventional treatment with topical Antibiotics
Eligibility
Sex/Gender
ALL
Age
18 Years to 86 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is 18-86 years old 2. Subject with Bacterial keratitis in one eye only 3. 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) 4. Best-corrected visual acuity of 6/60 or better in the uninvolved eye 5. No prior antibiotic treatment for current Bacterial Keratitis 6. 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
1. Perforation or imminent perforation of cornea 2. Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb 3. Sign of inflammation in both eyes 4. Severe itching suggesting viral infection or allergy reaction 5. Subepithelial infiltrate suggesting viral infection 6. Dendrite like ulcer or suspecting of Herpes keratitis 7. Previous penetrating keratoplasty 8. No light perception in the affected eye 9. Pregnancy 10. Other active ocular infection 11. Any infiltration suggesting other than bacterial infection e.g. parasite, fungal 12. Any corneal transplant 13. Post refractive surgery 14. Corneal inlays 15. Any other condition which in the opinion of the investigator would place the patient at undue risk for participation. 16. Participation in another clinical study within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bacterial Keratitis severity score | From date of randomization up to 14 days | Will be measured by Bacterial keratitis severity score (0-5). A low score is considered an improvement, a high score is considered worsening. |
Countries
Israel
Outcome results
None listed