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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. Identifier: NCT03845374
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : November 30, 2021
Information provided by (Responsible Party):
Eye-yon Medical

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.

Condition or disease Intervention/treatment Phase
Bacterial Keratitis Device: Hyper-CL™ lens Not Applicable

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.

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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:

  • Treatment Group 1: Conventional treatment of topical Antibiotics+ Hyper-CL lens
  • Treatment Group 2: Conventional treatment with topical Antibiotics
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

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03845374

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Rambam Medical Center
Haifa, Israel, 3109601
Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Eye-yon Medical
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Responsible Party: Eye-yon Medical 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

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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
Additional relevant MeSH terms:
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Corneal Diseases
Eye Diseases