- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01890252
Hyper-CL™ Lens (Hyper Osmotic Contact Lens) In Subjects Suffering From Corneal Edema
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
Conditions
Intervention / Treatment
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.
- Subject is over 18 years old
- Subject with clinical corneal edema
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Petach Tikva, Israel, 49774
- Rabin Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is over 18 years old
- Subject with clinical corneal edema
- Subject with visual acuity of 6/20 or worse (equivalent ETDRS)
Exclusion Criteria:
- Subject with active Herpes keratitis
- Subject with scarred cornea
- Subject who is suffering from erosions & infections of the cornea
- Subject who require chronic administration of any topical ophthalmic beside lubrication eye drops and steroids or anti glaucoma drags
- Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days
Study Plan
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:
|
Active Comparator: saline solution
hypertonic solution
|
saline solution of 5% NaCl
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Irit Bachar, Md, Cornea physician
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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