Hyper-CL™ Lens (Hyper Osmotic Contact Lens) In Subjects Suffering From Corneal Edema
Status:
Unknown status
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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: 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.