Status:
COMPLETED
Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis
Lead Sponsor:
Eye-yon Medical
Conditions:
Bacterial Keratitis
Eligibility:
All Genders
18-86 years
Phase:
NA
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 Antibi...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
- Subepithelial infiltrate suggesting viral infection
- Dendrite like ulcer or suspecting of Herpes keratitis
- Previous penetrating keratoplasty
- No light perception in the affected eye
- Pregnancy
- Other active ocular infection
- Any infiltration suggesting other than bacterial infection e.g. parasite, fungal
- Any corneal transplant
- Post refractive surgery
- Corneal inlays
- Any other condition which in the opinion of the investigator would place the patient at undue risk for participation.
- Participation in another clinical study within the past 30 days
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03845374
Start Date
March 13 2019
End Date
January 11 2021
Last Update
November 30 2021
Active Locations (2)
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1
Rambam Medical Center
Haifa, Israel, 3109601
2
Sheba Medical Center
Ramat Gan, Israel, 52621