Trial record 18 of 42 for:    Open Studies | "Contact Lenses"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by EyeYon Medical
Sponsor:
Information provided by (Responsible Party):
EyeYon Medical
ClinicalTrials.gov Identifier:
NCT01890252
First received: June 25, 2013
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Corneal Edema
Device: Hyper CL
Drug: saline solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized Crossover Study Of The Hyper-CL™ Lens (Hyper Osmotic Contact Lens) In Subjects Suffering From Corneal Edema

Resource links provided by NLM:


Further study details as provided by EyeYon Medical:

Primary Outcome Measures:
  • corneal thickness [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • visual acuity [ Time Frame: 1 month ] [ Designated as safety issue: No ]

    Measurement of distance visual acuity:

    Best Corrected Distance Visual Acuity (BCDVA)



Other Outcome Measures:
  • Subject comfort [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    the comfort and pain relief


Estimated Enrollment: 25
Study Start Date: July 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyper CL
Hyper osmotic contact lens
Device: Hyper CL
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
Device: Hyper CL
The Hyper CL is hyper osmotic contact lens that absorb fluids from the cornea and by that reduces corneal edema.
Drug: saline solution
saline solution of 5% NaCl
Other Name: hyper-tonic solution
Active Comparator: saline solution
hypertonic solution
Drug: saline solution
saline solution of 5% NaCl
Other Name: hyper-tonic solution

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890252

Locations
Israel
Rabin Medical Center Not yet recruiting
Petach Tikva, Israel, 49774
Contact: Vivi Dagan    +972-3-9377199    eyeclinic@clalit.org.il   
Sponsors and Collaborators
EyeYon Medical
Investigators
Principal Investigator: Irit Bachar, Md Cornea physician
  More Information

No publications provided

Responsible Party: EyeYon Medical
ClinicalTrials.gov Identifier: NCT01890252     History of Changes
Other Study ID Numbers: ECL00005
Study First Received: June 25, 2013
Last Updated: June 27, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Corneal Edema
Edema
Stress, Psychological
Corneal Diseases
Eye Diseases
Signs and Symptoms
Behavioral Symptoms
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014