CORNEAL EDEMANCT02660151
Study of Using the Hyper-CL™ Lens (Hyper Osmotic Contact Lens) in Subjects Suffering From Corneal Edema
A study testing Hyper-CL™ lens, Regular soft contact lens and Salt solution in people with CORNEAL EDEMA, run by Eye-yon Medical at 4 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CORNEAL EDEMA
- What is being tested?
- Hyper-CL™ lens, Regular soft contact lens and Salt solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2016to 28 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is over 18 years old
- Subject with corneal edema in the visual access
- Subject with visual acuity of 6/20 or worse (equivalent ETDRS) clinically explained by corneal edema
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
Who cannot join
- Subject with active Herpes keratitis
- Subject with scarred cornea
- Subject who is suffering from erosions and/or infections of the cornea (red eye)
- Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
About this study
Official title: 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.
Read the 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
- Conditions
- CORNEAL EDEMA
- Being tested
- Hyper-CL™ lens, Regular soft contact lens, Salt solution
- Medical subject headings
- Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyper-CL™ lensDevice
Regular soft contact lensDevice
Salt solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A-B | Experimental | 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. Receives: Device: Hyper-CL™ lens; Device: Regular soft contact lens; Drug: Salt solution |
| Treatment B-A | Experimental | 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. Receives: Device: Hyper-CL™ lens; Device: Regular soft contact lens; Drug: Salt solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency and severity of all treatment-related adverse events
Measured: 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
Measured: Up to 28 days (or 21 days if wash out is not needed).
Secondary outcomes (5)
Percent of subjects with corneal thickness decrease of at least 8%.
assess by physiological parameter
Measured: 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
Measured: Up to 28 days (or 21 days if wash out is not needed).
Corneal thickness decrease
assess by physiological parameter
Measured: Up to 28 days (or 21 days if wash out is not needed).
change in Measurement Best Corrected Distance Visual Acuity (BCDVA)
Measured: Up to 28 days (or 21 days if wash out is not needed).
change in Subject comfort questionnaire
Measured: Up to 28 days (or 21 days if wash out is not needed).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CORNEAL EDEMAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye-yon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660151
- Sponsor's protocol ID
- ECL00030
- Status last verified
- May 2019
- First submitted
- 11 Jan 2016
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 33014443
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Crossover Study of Using the Hyper-CL™ Lens (Hyper Osmotic Contact Lens) in Subjects Suffering From Corneal Edema
- ClinicalTrials.gov ID
- NCT02660151
- Acronym / sponsor ID
- ECL00030
- Conditions
- CORNEAL EDEMA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Eye-yon MedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A-B | Experimental | Device: Hyper-CL™ lens, Device: Regular soft contact lens, Drug: Salt solutionTreatment 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 | Experimental | Device: Hyper-CL™ lens, Device: Regular soft contact lens, Drug: Salt solutionTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is over 18 years old
- Subject with corneal edema in the visual access
- Subject with visual acuity of 6/20 or worse (equivalent ETDRS) clinically explained by corneal edema
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
Key exclusion criteria (6 listed)
- Subject with active Herpes keratitis
- Subject with scarred cornea
- Subject who is suffering from erosions and/or infections of the cornea (red eye)
- Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb
- Subject who require chronic administration of any topical ophthalmic beside lubrication eye drops and steroids or anti glaucoma drags
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyper-CL™ lens | Device | Treatment A-B, Treatment B-A |
| Regular soft contact lens | Device | Treatment A-B, Treatment B-A |
| Salt solution | Drug | Treatment A-B, Treatment B-A |
Primary outcome
frequency and severity of all treatment-related adverse events
Time frame: 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
Time frame: Up to 28 days (or 21 days if wash out is not needed).
assess by physiological parameter
5 secondary outcomes
Percent of subjects with corneal thickness decrease of at least 8%.
Time frame: 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
Time frame: Up to 28 days (or 21 days if wash out is not needed).
Corneal thickness decrease
Time frame: Up to 28 days (or 21 days if wash out is not needed).
change in Measurement Best Corrected Distance Visual Acuity (BCDVA)
Time frame: Up to 28 days (or 21 days if wash out is not needed).
change in Subject comfort questionnaire
Time frame: Up to 28 days (or 21 days if wash out is not needed).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Derived from this study: PubMed 33014443Daphna 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyper-CL™ lens, Regular soft contact lens and Salt solution in people with CORNEAL EDEMA, run by Eye-yon Medical at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency and severity of all treatment-related adverse events (time frame: Up to 28 days (or 21 days if wash out is not needed).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02660151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.