Health Condition 1: H160- Corneal ulcer
Conditions
Interventions
Intervention1: Hyper-CL Lens: Hyper-CL lens along with Moxifloxacin 0.5% w/v topical eye drops 6 times a day till resolution of infection
Control Intervention1: Antibiotics Alone: Moxifloxacin 0.5% w/
Sponsors
EyeYon Medical Ltd
Eligibility
Inclusion criteria
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
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 |
|---|---|
| Change in Bacterial Keratitis severity scoreTimepoint: 14th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time for significant improvement in Bacterial Keratitis severity score (at least 2 points decrease) 2. Change in Bacterial Keratitis score over time 3. Change from baseline in Pain score over time 4. Change in Visual Acuity over timeTimepoint: 1st day, 2nd day, 3rd day, 5th day and 14th day | — |
Countries
India
Contacts
Public ContactProf A Heber
Dr. Agarwals Eye Hospital
Outcome results
None listed