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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective, Randomized Crossover Study of Using 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.


Detailed Summary:

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 20 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


Sponsor: Eye-yon Medical

Current Primary Outcome:

  • frequency and severity of all treatment-related adverse events [ Time Frame: Up to 28 days (or 21 days if wash out is not needed). ]
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • Corneal thickness decrease [ Time Frame: Up to 28 days (or 21 days if wash out is not needed). ]
    assess by physiological parameter
  • change in Measurement Best Corrected Distance Visual Acuity (BCDVA) [ Time Frame: Up to 28 days (or 21 days if wash out is not needed). ]
  • change in Subject comfort questionnaire [ Time Frame: Up to 28 days (or 21 days if wash out is not needed). ]


Original Secondary Outcome: Same as current

Information By: Eye-yon Medical

Dates:
Date Received: January 11, 2016
Date Started: February 2016
Date Completion: February 2017
Last Updated: November 27, 2016
Last Verified: September 2016