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

NCT03845374 | Completed

• 1 other identifier: CLI-H004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Bacterial Keratitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conventional Antibiotics+ Hyper-CL™ lens

EXPERIMENTAL

Conventional treatment with topical Antibiotics+ Hyper-CL™ lens

Device: Hyper-CL™ lens

Conventional Antibiotics

NO INTERVENTION

Conventional treatment with topical Antibiotics

Interventions

Hyper-CL™ lens DEVICE

Use of the Hyper-CL™

Conventional Antibiotics+ Hyper-CL™ lens

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye-yon Medical: lead

Study Sites (2)

Rambam Medical Center

Haifa, 3109601, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 19, 2019
• Study Start: March 13, 2019
• Primary Completion: December 22, 2020
• Study Completion: January 11, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Locations

IL (2)