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
About this trial
This is an interventional treatment trial for Bacterial Keratitis
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
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
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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