Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 86 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

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

Contacts and Locations

Locations

Israel

Rambam Medical Center

Haifa, Israel, 3109601

Sheba Medical Center

Ramat Gan, Israel, 52621

Sponsors and Collaborators

Eye-yon Medical

More Information

• Responsible Party: Eye-yon Medical
• ClinicalTrials.gov Identifier: NCT03845374
• Other Study ID Numbers: CLI-H004
• First Posted: February 19, 2019
• 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

Additional relevant MeSH terms:

Keratitis; Corneal Diseases; Eye Diseases