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

NCT01890252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-11-11

No results posted yet for this study

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.

Conditions

  • Corneal Edema

Interventions

DEVICE

Hyper CL

The Hyper CL is hyper osmotic contact lens that absorb fluids from the cornea and by that reduces corneal edema.

DRUG

saline solution

saline solution of 5% NaCl

Sponsors & Collaborators

  • Eye-yon Medical

    lead INDUSTRY

Principal Investigators

  • Irit Bachar, Md · Cornea physician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-01-31
Completion
2014-04-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01890252 on ClinicalTrials.gov