Hyper-CL™ Lens (Hyper Osmotic Contact Lens) In Subjects Suffering From Corneal Edema

November 4, 2021 updated by: Eye-yon Medical

Prospective, Randomized Crossover Study Of The Hyper-CL™ Lens (Hyper Osmotic Contact Lens) In Subjects Suffering From Corneal Edema

The Hyper-CL™ lenses are indicated for therapeutic use as a bandage to protect the corneal surface and to relieve corneal pain in the treatment of acute or chronic ocular pathologies, such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

In addition Hyper-CL™ contact lenses can also provide optical correction during healing if required.

Prospective open-label, randomized, crossover clinical study To evaluate the safety and efficacy of the Hyper-CL™ lens in subjects suffering from corneal edema.

This study is designed to evaluate the efficacy of the Hyper-CL™ lens contact lens on corneal edema thickness as compared with salt solution treatment only in subjects suffering from corneal edema.

Treatment with the Hyper-CL™ lens may result with greater reduction in edema thickness as compared with treatment with salt solution only in subjects suffering from corneal edema.

Men and women suffering from a decrease in vision due to corneal edema that meet the inclusion/exclusion criteria and provide written Informed Consent will be enrolled in the study.

A total of 25 subjects will be enrolled. Each subject will be treated with:

  • Treatment A: Hyper-CL™ lens only (7 days)
  • Treatment B: Hyper-CL™ lens + salt solution (7 days)
  • Treatment C: salt solution only (7 days) One week (7 days) of washout without any treatment will be between treatments. Subject will be equally allocated (with a 1:1:1:1:1:1 ratio) to one of the following 6 crossover regimen based on a randomization scheme with blocks stratified by center: C-A-B; B-C-A; A-B-C; C-B-A; B-A-C; A-C-B.

Up to 2 centers will participate in this study. Each subject will be followed from baseline to 42 days. All Subjects will come for a clinic visit at 7, 14, 21, 28, 35 and 42 days post first treatment.

Completion of active enrolment is anticipated to last approximately 6 months. The primary end point will be achieved when the final study subject has completed 42 day follow-up.

Study Overview

Status

Completed

Conditions

Detailed Description

Prospective, randomized crossover study of the Hyper-CL™ lens (Hyper osmotic Contact Lens) in subjects suffering from corneal edema Hyper-CL™ lens (Hyper osmotic Contact Lens) The Hyper-CL™ lenses are indicated for therapeutic use as a bandage to protect the corneal surface and to relieve corneal pain in the treatment of acute or chronic ocular pathologies, such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

In addition Hyper-CL™ contact lenses can also provide optical correction during healing if required.

Prospective open-label, randomized, crossover clinical study To evaluate the safety and efficacy of the Hyper-CL™ lens in subjects suffering from corneal edema.

This study is designed to evaluate the efficacy of the Hyper-CL™ lens contact lens on corneal edema thickness as compared with salt solution treatment only in subjects suffering from corneal edema.

Treatment with the Hyper-CL™ lens may result with greater reduction in edema thickness as compared with treatment with salt solution only in subjects suffering from corneal edema.

Men and women suffering from a decrease in vision due to corneal edema that meet the inclusion/exclusion criteria and provide written Informed Consent will be enrolled in the study.

A total of 25 subjects will be enrolled. Each subject will be treated with:

  • Treatment A: Hyper-CL™ lens only (7 days)
  • Treatment B: Hyper-CL™ lens + salt solution (7 days)
  • Treatment C: salt solution only (7 days) One week (7 days) of washout without any treatment will be between treatments. Subject will be equally allocated (with a 1:1:1:1:1:1 ratio) to one of the following 6 crossover regimen based on a randomization scheme with blocks stratified by center: C-A-B; B-C-A; A-B-C; C-B-A; B-A-C; A-C-B.

Up to 2 centers will participate in this study. Each subject will be followed from baseline to 42 days. All Subjects will come for a clinic visit at 7, 14, 21, 28, 35 and 42 days post first treatment.

Completion of active enrolment is anticipated to last approximately 6 months. The primary end point will be achieved when the final study subject has completed 42 day follow-up.

The frequency and severity of all treatment-related adverse events, during and after using the Hyper-CL™ lens. Adverse events will be assessed on a continuous basis from the first procedure through the study completion at 42 days. Related adverse events include: infectious keratitis, allergic or toxic inflammatory reaction, significant increase in corneal edema.

Percent of subjects with corneal thickness decrease by at least 8% following treatment with the Hyper-CL™ lens + salt solution.

  • Corneal thickness decrease following treatment with the Hyper-CL™ lens + salt solution
  • Percent of subjects with corneal thickness decrease by at least 8% following treatment with the Hyper-CL™ lens only
  • Corneal thickness decrease following treatment with the Hyper-CL™ lens only
  • Measurement of distance visual acuity:

    o Best Corrected Distance Visual Acuity (BCDVA)

  • Subject comfort

Subjects will be treated with:

A: Treatment with Hyper-CL™ lens only B: Treatment with Hyper-CL™ lens + salt solution C: Treatment with salt solution only Each subject will be treated with all three treatments according to his allocated regimen treatment.

  1. Subject is over 18 years old
  2. Subject with clinical corneal edema
  3. Subject with visual acuity of 6/20 or worse (equivalent ETDRS)

1. Subject with active Herpes keratitis 2. Subject with scarred cornea 3. Subject who is suffering from erosions & infections of the cornea 4. Subject who require chronic administration of any topical ophthalmic beside lubrication eye drops and steroids or anti glaucoma drags 5. Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days

Baseline: The visit will include subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed.

Complete anamnesis will be taken including subject's medical complaints, medical history, and medication use.

Ophthalmic examinations. Subject will be randomized to one of the 6 crossover regimen treatments.

Day 0: Subject will be asked to stop using any treatment for 7 days (beside steroid drops or anti glaucoma drops) and will have the following procedures/visits:

Day 7: subject will have clinical follow-up and will begin with first treatment (A, B or C) according to his treatment regimen.

Day 14: subject will have clinical follow-up and will stop the treatment. Day 21: subject will have clinical follow-up and will begin with the second treatment.

Day 28: subject will have clinical follow-up and will stop the treatment. Day 35: subject will have clinical follow-up and will begin the third treatment.

Day 42: subject will have clinical follow-up. All visits will include ophthalmic examinations, medications used and recording of adverse events. 42 days follow-up visit will include a satisfaction questionnaire.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Petach Tikva, Israel, 49774
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is over 18 years old
  2. Subject with clinical corneal edema
  3. Subject with visual acuity of 6/20 or worse (equivalent ETDRS)

Exclusion Criteria:

  1. Subject with active Herpes keratitis
  2. Subject with scarred cornea
  3. Subject who is suffering from erosions & infections of the cornea
  4. Subject who require chronic administration of any topical ophthalmic beside lubrication eye drops and steroids or anti glaucoma drags
  5. Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyper CL
Hyper osmotic contact lens
The Hyper CL is hyper osmotic contact lens that absorb fluids from the cornea and by that reduces corneal edema.
Experimental: Hyper CL + Saline solution
combined treatment of hyper osmotic contact lens+ hypertonic solution
The Hyper CL is hyper osmotic contact lens that absorb fluids from the cornea and by that reduces corneal edema.
saline solution of 5% NaCl
Other Names:
  • hyper-tonic solution
Active Comparator: saline solution
hypertonic solution
saline solution of 5% NaCl
Other Names:
  • hyper-tonic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corneal thickness
Time Frame: 1 month
Primary endpoint will be the percent of subjects with corneal thickness decrease of at least 8% during the one week treatment with the Hyper-CL™ lens + salt solution.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual acuity
Time Frame: 1 month

Measurement of distance visual acuity:

Best Corrected Distance Visual Acuity (BCDVA)

1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject comfort
Time Frame: 1 month
the comfort and pain relief
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Irit Bachar, Md, Cornea physician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

January 31, 2014

Study Completion (Actual)

April 30, 2014

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

July 1, 2013

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ECL00005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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