Prospective, Randomized Multi-Center Study of Using the H... | NCT03845374

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

NCT03845374

Sponsor

Eye-yon Medical

Status

Completed

Last Update Posted

Nov 30, 2021Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Bacterial Keratitis

Interventions

Hyper-CL™ lens

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 13, 2019Actual

Primary Completion Date

Dec 22, 2020Actual

Completion Date

Jan 11, 2021Actual

First Submitted Date

Feb 7, 2019

First Submission Date that Met QC Criteria

Feb 17, 2019

First Posted Date

Feb 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2021

Last Update Posted Date

Nov 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hyper-CL™ lens	Device	Use of the Hyper-CL™	Conventional Antibiotics+ Hyper-CL™ lens

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

86 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Medical Center		Haifa		3109601	Israel
Sheba Medical Center