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

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Keratitis
• Intervention / Treatment: Device: Hyper-CL™ lens

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 86 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bacterial Keratitis severity score	Will be measured by Bacterial keratitis severity score (0-5). A low score is considered an improvement, a high score is considered worsening.	From date of randomization up to 14 days

Collaborators and Investigators

• Sponsor: Eye-yon Medical

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 13, 2019
• Primary Completion (ACTUAL): December 22, 2020
• Study Completion (ACTUAL): January 11, 2021

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 17, 2019
• First Posted (ACTUAL): February 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratitis
• Other Study ID Numbers: CLI-H004

Drug and device information, study documents

• 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