Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03845374 |
Recruitment Status :
Completed
First Posted : February 19, 2019
Last Update Posted : November 30, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bacterial Keratitis | Device: Hyper-CL™ lens | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 40 patients will be randomized to one of the following 2 groups:
|
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis |
Actual Study Start Date : | March 13, 2019 |
Actual Primary Completion Date : | December 22, 2020 |
Actual Study Completion Date : | January 11, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Conventional Antibiotics+ Hyper-CL™ lens
Conventional treatment with topical Antibiotics+ Hyper-CL™ lens
|
Device: Hyper-CL™ lens
Use of the Hyper-CL™ |
No Intervention: Conventional Antibiotics
Conventional treatment with topical Antibiotics
|
- Change in Bacterial Keratitis severity score [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 86 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845374
Israel | |
Rambam Medical Center | |
Haifa, Israel, 3109601 | |
Sheba Medical Center | |
Ramat Gan, Israel, 52621 |
Responsible Party: | Eye-yon Medical |
ClinicalTrials.gov Identifier: | NCT03845374 |
Other Study ID Numbers: |
CLI-H004 |
First Posted: | February 19, 2019 Key Record Dates |
Last Update Posted: | November 30, 2021 |
Last Verified: | November 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Keratitis Corneal Diseases Eye Diseases |