Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01890252 |
| Other study ID # |
ECL00005 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2013 |
| Est. completion date |
April 30, 2014 |
Study information
| Verified date |
February 2019 |
| Source |
Eye-yon Medical |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| 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.
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.
Description:
Prospective, randomized crossover study of the Hyper-CL™ lens (Hyper osmotic Contact Lens) in
subjects suffering from corneal edema Hyper-CL™ lens (Hyper osmotic Contact Lens) 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.
The frequency and severity of all treatment-related adverse events, during and after using
the Hyper-CL™ lens. Adverse events will be assessed on a continuous basis from the first
procedure through the study completion at 42 days. Related adverse events include: infectious
keratitis, allergic or toxic inflammatory reaction, significant increase in corneal edema.
Percent of subjects with corneal thickness decrease by at least 8% following treatment with
the Hyper-CL™ lens + salt solution.
- Corneal thickness decrease following treatment with the Hyper-CL™ lens + salt solution
- Percent of subjects with corneal thickness decrease by at least 8% following treatment
with the Hyper-CL™ lens only
- Corneal thickness decrease following treatment with the Hyper-CL™ lens only
- Measurement of distance visual acuity:
o Best Corrected Distance Visual Acuity (BCDVA)
- Subject comfort
Subjects will be treated with:
A: Treatment with Hyper-CL™ lens only B: Treatment with Hyper-CL™ lens + salt solution C:
Treatment with salt solution only Each subject will be treated with all three treatments
according to his allocated regimen treatment.
1. Subject is over 18 years old
2. Subject with clinical corneal edema
3. Subject with visual acuity of 6/20 or worse (equivalent ETDRS)
1. Subject with active Herpes keratitis 2. Subject with scarred cornea 3. Subject who is
suffering from erosions & infections of the cornea 4. Subject who require chronic
administration of any topical ophthalmic beside lubrication eye drops and steroids or anti
glaucoma drags 5. Subject who is currently participating or have participated in an
investigational study, other than this study, within the past 60 days
Baseline: The visit will include subject's qualification assessment for inclusion/exclusion
criteria as described above. Informed consent must be signed.
Complete anamnesis will be taken including subject's medical complaints, medical history, and
medication use.
Ophthalmic examinations. Subject will be randomized to one of the 6 crossover regimen
treatments.
Day 0: Subject will be asked to stop using any treatment for 7 days (beside steroid drops or
anti glaucoma drops) and will have the following procedures/visits:
Day 7: subject will have clinical follow-up and will begin with first treatment (A, B or C)
according to his treatment regimen.
Day 14: subject will have clinical follow-up and will stop the treatment. Day 21: subject
will have clinical follow-up and will begin with the second treatment.
Day 28: subject will have clinical follow-up and will stop the treatment. Day 35: subject
will have clinical follow-up and will begin the third treatment.
Day 42: subject will have clinical follow-up. All visits will include ophthalmic
examinations, medications used and recording of adverse events. 42 days follow-up visit will
include a satisfaction questionnaire.
