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

NCT01890252 | Completed DMC

• 1 other identifier: ECL00005
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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. 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

Outcome Measures

Primary Outcomes (1)

• corneal thickness

  Primary endpoint will be the percent of subjects with corneal thickness decrease of at least 8% during the one week treatment with the Hyper-CL™ lens + salt solution.

  1 month

Secondary Outcomes (1)

• visual acuity

  1 month

Other Outcomes (1)

• Subject comfort

  1 month

Study Arms (3)

Hyper CL

EXPERIMENTAL

Hyper osmotic contact lens

Device: Hyper CL

Hyper CL + Saline solution

EXPERIMENTAL

combined treatment of hyper osmotic contact lens+ hypertonic solution

Device: Hyper CL; Drug: saline solution

saline solution

ACTIVE COMPARATOR

hypertonic solution

Drug: saline solution

Interventions

Hyper CL DEVICE

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

Hyper CL; Hyper CL + Saline solution

saline solution DRUG

saline solution of 5% NaCl

Also known as: hyper-tonic solution

Hyper CL + Saline solution; saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is over 18 years old
• Subject with clinical corneal edema
• Subject with visual acuity of 6/20 or worse (equivalent ETDRS)

You may not qualify if:

• Subject with active Herpes keratitis
• Subject with scarred cornea
• Subject who is suffering from erosions \& infections of the cornea
• Subject who require chronic administration of any topical ophthalmic beside lubrication eye drops and steroids or anti glaucoma drags
• Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days

Sponsors & Collaborators

• Eye-yon Medical: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49774, Israel

Location

MeSH Terms

Conditions

Corneal Edema

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Irit Bachar, Md

  Cornea physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 1, 2013
• Study Start: July 1, 2013
• Primary Completion: January 31, 2014
• Study Completion: April 30, 2014
• Last Updated: November 11, 2021

Record last verified: 2019-02

Locations

IL (1)