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Study of Using the Hyper-CL™ Lens (Hyper Osmotic Contact Lens) in Subjects Suffering From Corneal Edema

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02660151
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Eye-yon Medical

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
CORNEAL EDEMA Device: Hyper-CL™ lens Device: Regular soft contact lens Drug: Salt solution Not Applicable

Detailed Description:

This study is a prospective, randomized crossover study. The primary aim of this study is to assess the safety and effectiveness of using the Hyper-CL™ lens +salt solution (5% NaCl) as compared with using regular contact lens + salt solution (5% NaCl) in subjects suffering from corneal edema. Safety will be assessed by evaluating the rate of adverse events and adverse device effects occurred throughout the study period. Effectiveness will be assessed by measuring changes in corneal thickness and visual acuity.

Subjects with corneal edema will be the study population. Only subjects who have signed the informed consent form and meet all the eligibility criteria listed below will be qualified for enrollment. The study will encompass a total of up to 80 subjects who will complete the Protocol follow-up schedule.

Each subject will be treated with:

Treatment A: Hyper-CL™ lens + salt solution + antibiotics drops (7 days) Treatment B: Regular soft contact lens +salt solution+ antibiotics drops (7 days) One week (7 days) of washout without any treatment will be between treatments. Subject will be equally allocated to one of the following 2 crossover regimen based on a randomization scheme with blocks stratified by center: A-B; B-A


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Crossover Study of Using the Hyper-CL™ Lens (Hyper Osmotic Contact Lens) in Subjects Suffering From Corneal Edema
Study Start Date : February 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : November 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Eye Wear
Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: Treatment A-B
Treatment A: Hyper-CL™ lens + salt solution + antibiotics drops (7 days) Treatment B: Regular soft contact lens +salt solution+ antibiotics drops (7 days) One week (7 days) of washout without any treatment will be between treatments.
Device: Hyper-CL™ lens
Device: Regular soft contact lens
Drug: Salt solution
Experimental: Treatment B-A
Treatment A: Hyper-CL™ lens + salt solution + antibiotics drops (7 days) Treatment B: Regular soft contact lens +salt solution+ antibiotics drops (7 days) One week (7 days) of washout without any treatment will be between treatments.
Device: Hyper-CL™ lens
Device: Regular soft contact lens
Drug: Salt solution



Primary Outcome Measures :
  1. frequency and severity of all treatment-related adverse events [ Time Frame: Up to 28 days (or 21 days if wash out is not needed). ]
  2. Percent of subjects with corneal thickness decrease of at least 8% and or visual acuity improvement of at least 1 line following treatment with the Hyper-CL™ lens + salt solution [ Time Frame: Up to 28 days (or 21 days if wash out is not needed). ]
    assess by physiological parameter


Secondary Outcome Measures :
  1. Percent of subjects with corneal thickness decrease of at least 8%. [ Time Frame: Up to 28 days (or 21 days if wash out is not needed). ]
    assess by physiological parameter

  2. Percent of subjects with visual acuity improvement of at least 1 line [ Time Frame: Up to 28 days (or 21 days if wash out is not needed). ]
    assess by physiological parameter

  3. Corneal thickness decrease [ Time Frame: Up to 28 days (or 21 days if wash out is not needed). ]
    assess by physiological parameter

  4. change in Measurement Best Corrected Distance Visual Acuity (BCDVA) [ Time Frame: Up to 28 days (or 21 days if wash out is not needed). ]
  5. change in Subject comfort questionnaire [ Time Frame: Up to 28 days (or 21 days if wash out is not needed). ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is over 18 years old
  2. Subject with corneal edema in the visual access
  3. Subject with visual acuity of 6/20 or worse (equivalent ETDRS) clinically explained by corneal edema
  4. 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. Subject with active Herpes keratitis
  2. Subject with scarred cornea
  3. Subject who is suffering from erosions and/or infections of the cornea (red eye)
  4. Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb
  5. Subject who require chronic administration of any topical ophthalmic beside lubrication eye drops and steroids or anti glaucoma drags
  6. Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days

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): NCT02660151


Locations
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Israel
Soroka MC
Beer- Sheva, Israel
Sheba MC
Ramat Gan, Israel
Poland
Katowice MC
Katowice, Poland
Lublin MC
Lublin, Poland
Sponsors and Collaborators
Eye-yon Medical

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Responsible Party: Eye-yon Medical
ClinicalTrials.gov Identifier: NCT02660151     History of Changes
Other Study ID Numbers: ECL00030
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Edema
Corneal Edema
Signs and Symptoms
Corneal Diseases
Eye Diseases
Pharmaceutical Solutions