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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

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:
  

  Detailed Summary:

  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 trea
  Sponsor: EyeYon Medical
  

  Current Primary Outcome: 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.
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome: visual acuity [ Time Frame: 1 month ]

  Measurement of distance visual acuity:

  Best Corrected Distance Visual Acuity (BCDVA)

  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: EyeYon Medical
  

  Dates:
  Date Received: June 25, 2013
  Date Started: July 2013
  Date Completion: April 2014
  Last Updated: June 27, 2013
  Last Verified: June 2013