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

Primary Purpose

Bacterial Keratitis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hyper-CL™ lens
Sponsored by
Eye-yon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Keratitis

Eligibility Criteria

18 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rambam Medical Center
  • Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Conventional Antibiotics+ Hyper-CL™ lens

Conventional Antibiotics

Arm Description

Conventional treatment with topical Antibiotics+ Hyper-CL™ lens

Conventional treatment with topical Antibiotics

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 7, 2019
Last Updated
November 18, 2021
Sponsor
Eye-yon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03845374
Brief Title
Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis
Official Title
Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
January 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye-yon Medical

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Keratitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Antibiotics+ Hyper-CL™ lens
Arm Type
Experimental
Arm Description
Conventional treatment with topical Antibiotics+ Hyper-CL™ lens
Arm Title
Conventional Antibiotics
Arm Type
No Intervention
Arm Description
Conventional treatment with topical Antibiotics
Intervention Type
Device
Intervention Name(s)
Hyper-CL™ lens
Intervention Description
Use of the Hyper-CL™
Primary Outcome Measure Information:
Title
Change in Bacterial Keratitis severity score
Description
Will be measured by Bacterial keratitis severity score (0-5). A low score is considered an improvement, a high score is considered worsening.
Time Frame
From date of randomization up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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