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

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.

Study Overview

• Status: Completed
• Conditions: CORNEAL EDEMA
• Intervention / Treatment: Device: Hyper-CL™ lens; Device: Regular soft contact lens; Drug: Salt solution

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Beer- Sheva, Israel
    • Soroka MC
  • Ramat Gan, Israel
    • Sheba MC
• Poland
  • Katowice, Poland
    • Katowice MC
  • Lublin, Poland
    • Lublin MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A-B; 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.	Device: Hyper-CL™ lens; Device: Regular soft contact lens; Drug: Salt solution
Experimental: Treatment B-A; 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.	Device: Hyper-CL™ lens; Device: Regular soft contact lens; Drug: Salt solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency and severity of all treatment-related adverse events		Up to 28 days (or 21 days if wash out is not needed).
Percent of subjects with corneal thickness decrease of at least 8% and or visual acuity improvement of at least 1 line following treatment with the Hyper-CL™ lens + salt solution	assess by physiological parameter	Up to 28 days (or 21 days if wash out is not needed).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of subjects with corneal thickness decrease of at least 8%.	assess by physiological parameter	Up to 28 days (or 21 days if wash out is not needed).
Percent of subjects with visual acuity improvement of at least 1 line	assess by physiological parameter	Up to 28 days (or 21 days if wash out is not needed).
Corneal thickness decrease	assess by physiological parameter	Up to 28 days (or 21 days if wash out is not needed).
change in Measurement Best Corrected Distance Visual Acuity (BCDVA)		Up to 28 days (or 21 days if wash out is not needed).
change in Subject comfort questionnaire		Up to 28 days (or 21 days if wash out is not needed).

Collaborators and Investigators

• Sponsor: Eye-yon Medical

Publications and helpful links

General Publications

• Daphna O, Mimouni M, Keshet Y, Ben Ishai M, Barequet IS, Knyazer B, Mrukwa-Kominek E, Zarnowski T, Chen-Zion M, Marcovich A. Therapeutic HL-Contact Lens versus Standard Bandage Contact Lens for Corneal Edema: A Prospective, Multicenter, Randomized, Crossover Study. J Ophthalmol. 2020 Sep 21;2020:8410920. doi: 10.1155/2020/8410920. eCollection 2020.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): November 28, 2018

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 17, 2016
• First Posted (Estimate): January 21, 2016

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 19, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Edema; Corneal Edema
• Other Study ID Numbers: ECL00030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided