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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03845374
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Eye-yon Medical

Study Description
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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.


Condition or disease Intervention/treatment Phase
Bacterial Keratitis Device: Hyper-CL™ lens Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in Bacterial keratitis severity score. [ Time Frame: From date of randomization up to 14 days ]
    Will be measured by Bacterial keratitis severity score


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is 18-86 years old
  2. Subject with Bacterial keratitis in one eye only

Exclusion Criteria:

  1. Sign of inflammation in both eyes
  2. Pregnancy
  3. Other active ocular infection
  4. Any infiltration suggesting other than bacterial infection e.g. parasite, fungal
  5. Any other condition which in the opinion of the investigator would place the patient at undue risk for participation.
  6. Participation in another clinical study within the past 30 days
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845374


Contacts
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Contact: Lori Michaeli, MA 972722052400 lori@novatrials.com

Locations
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Israel
Rambam Medical Center Recruiting
Haifa, Israel, 3109601
Contact: Meital Abecassis    9724777-1130    m_abecassis@rambam.health.gov.il   
Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Rinat Rashty    97235302877    Rinat.Rashty@sheba.health.gov.il   
Sponsors and Collaborators
Eye-yon Medical
More Information
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Responsible Party: Eye-yon Medical
ClinicalTrials.gov Identifier: NCT03845374    
Other Study ID Numbers: CLI-H004
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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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
Additional relevant MeSH terms:
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Keratitis
Corneal Diseases
Eye Diseases
Anti-Bacterial Agents
 Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents