CORNEAL EDEMA Clinical Trial
Official title:
Prospective, Randomized Crossover Study of Using the Hyper-CL™ Lens (Hyper Osmotic Contact Lens) in Subjects Suffering From Corneal Edema
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.
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 up to 80 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
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