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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Corneal Edema

Intervention / Treatment
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* Device: Hyper CL
* Drug: saline solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal thickness | 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 | Measurement of distance visual acuity: Best Corrected Distance Visual Acuity (BCDVA) | 1 month |