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

• Status: Completed
• Trial end date: 2018-11-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eye-yon Medical
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Subject is over 18 years old

2. Subject with corneal edema in the visual access

3. Subject with visual acuity of 6/20 or worse (equivalent ETDRS) clinically explained by corneal edema

4. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

Exclusion Criteria:

1. Subject with active Herpes keratitis

2. Subject with scarred cornea

3. Subject who is suffering from erosions and/or infections of the cornea (red eye)

4. Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb

5. Subject who require chronic administration of any topical ophthalmic beside lubrication eye drops and steroids or anti glaucoma drags

6. Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days