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

Not Applicable

Completed

• Conditions: CORNEAL EDEMA
• Interventions: Device: Hyper-CL™ lens; Device: Regular soft contact lens; Drug: Salt solution

• Registration Number: NCT02660151
• Lead Sponsor: Eye-yon Medical

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.

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 Timeline

• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-17
• Study First Posted: 2016-01-21
• Study Start: 2016-02
• Primary Completion: 2018-10
• Study Completion: 2018-11-28
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-19
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A-B	Regular soft contact lens	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.
Treatment A-B	Salt solution	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.
Treatment B-A	Regular soft contact lens	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.
Treatment A-B	Hyper-CL™ lens	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.
Treatment B-A	Hyper-CL™ lens	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.
Treatment B-A	Salt solution	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.

Primary Outcome Measures

Name	Time	Method
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	Up to 28 days (or 21 days if wash out is not needed).	assess by physiological parameter

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Katowice MC; 🇵🇱 Katowice, Poland

Soroka MC; 🇮🇱 Beer- Sheva, Israel

Sheba MC; 🇮🇱 Ramat Gan, Israel

Lublin MC; 🇵🇱 Lublin, Poland