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

CORNEAL EDEMA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660151
• Other study ID #: ECL00030
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: November 28, 2018

Study information

• Verified date: May 2019
• Source: Eye-yon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 28, 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CORNEAL EDEMA
• Edema

Intervention

Device:
• Hyper-CL™ lens

• Regular soft contact lens

Drug:
• Salt solution

Locations

Country	Name	City	State
Israel	Soroka MC	Beer- Sheva
Israel	Sheba MC	Ramat Gan
Poland	Katowice MC	Katowice
Poland	Lublin MC	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Eye-yon Medical

Countries where clinical trial is conducted

Israel,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency and severity of all treatment-related adverse events		Up to 28 days (or 21 days if wash out is not needed).
Primary	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	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).
Secondary	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).
Secondary	Corneal thickness decrease	assess by physiological parameter	Up to 28 days (or 21 days if wash out is not needed).
Secondary	change in Measurement Best Corrected Distance Visual Acuity (BCDVA)		Up to 28 days (or 21 days if wash out is not needed).
Secondary	change in Subject comfort questionnaire		Up to 28 days (or 21 days if wash out is not needed).