Bacterial KeratitisNCT03845374
Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis
A study testing Hyper-CL™ lens in people with Bacterial Keratitis, run by Eye-yon Medical at 2 sites in Israel.
Trial summary
This study is a prospective, randomized, open-label, two arms, clinical study aim to evaluate the efficacy and safety of treatment with Hyper-CL™ lens + Antibiotics compared with treatment with Antibiotics only, in subjects with Bacterial keratitis. Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Bacterial Keratitis
- What is being tested?
- Hyper-CL™ lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesIsrael
- Study dates
- 13 Mar 2019to 11 Jan 2021
- 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 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18-86 years old
- Subject with Bacterial keratitis in one eye only
- Subject with Bacterial Keratitis of at least grade 2 score in Average length of infiltration and in Average length of epithelial defect (1mm or above)
- Best-corrected visual acuity of 6/60 or better in the uninvolved eye
- No prior antibiotic treatment for current Bacterial Keratitis
- 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
- Perforation or imminent perforation of cornea
- Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb
- Sign of inflammation in both eyes
- Severe itching suggesting viral infection or allergy reaction
- Subepithelial infiltrate suggesting viral infection
- Dendrite like ulcer or suspecting of Herpes keratitis
Show all 16Show fewer
- Previous penetrating keratoplasty
- No light perception in the affected eye
- Pregnancy
- Other active ocular infection
- Any infiltration suggesting other than bacterial infection e.g. parasite, fungal
- Any corneal transplant
- Post refractive surgery
- Corneal inlays
- Any other condition which in the opinion of the investigator would place the patient at undue risk for participation.
- Participation in another clinical study within the past 30 days
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Rambam Medical Center
Haifa, 3109601
Sheba Medical Center
Ramat Gan, 52621
About this study
This study is a prospective, randomized, open-label, two arms, clinical study aim to evaluate the efficacy and safety of treatment with Hyper-CL™ lens + Antibiotics compared with treatment with Antibiotics only, in subjects with Bacterial keratitis.
The design of the Hyper-CL™ lens increases contact time of the antibiotics on the cornea enabling increased bioavailability of the active drug.
Read the detailed description
The Hyper-CL™ Therapeutic soft contact lenses for short-term wear (up to 7 days) are indicated for therapeutic use to promote corneal healing and relieve corneal pain by protecting the cornea during the treatment of acute or chronic pathologies, such as corneal edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery.
- Conditions
- Bacterial Keratitis
- Being tested
- Hyper-CL™ lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyper-CL™ lensDevice
Use of the Hyper-CL™
| Study group | Role | What they receive |
|---|---|---|
| Conventional Antibiotics+ Hyper-CL™ lens | Experimental | Conventional treatment with topical Antibiotics+ Hyper-CL™ lens Receives: Device: Hyper-CL™ lens |
| Conventional Antibiotics | No intervention | Conventional treatment with topical Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bacterial Keratitis severity score
Will be measured by Bacterial keratitis severity score (0-5). A low score is considered an improvement, a high score is considered worsening.
Measured: From date of randomization up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start13 Mar 2019
- Primary completion22 Dec 2020
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial KeratitisStudies 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
- Parallel groups
- Model description
- 40 patients will be randomized to one of the following 2 groups: * Treatment Group 1: Conventional treatment of topical Antibiotics+ Hyper-CL lens * Treatment Group 2: Conventional treatment with topical Antibiotics
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT03845374
- Sponsor's protocol ID
- CLI-H004
- Status last verified
- Nov 2021
- First submitted
- 7 Feb 2019
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis
- ClinicalTrials.gov ID
- NCT03845374
- Acronym / sponsor ID
- CLI-H004
- Conditions
- Bacterial Keratitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eye-yon MedicalIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 19 Feb 2019 (actual)
- 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.
This study is a prospective, randomized, open-label, two arms, clinical study aim to evaluate the efficacy and safety of treatment with Hyper-CL™ lens + Antibiotics compared with treatment with Antibiotics only, in subjects with Bacterial keratitis.
The design of the Hyper-CL™ lens increases contact time of the antibiotics on the cornea enabling increased bioavailability of the active drug.
Detailed description
The Hyper-CL™ Therapeutic soft contact lenses for short-term wear (up to 7 days) are indicated for therapeutic use to promote corneal healing and relieve corneal pain by protecting the cornea during the treatment of acute or chronic pathologies, such as corneal edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 40 patients will be randomized to one of the following 2 groups: * Treatment Group 1: Conventional treatment of topical Antibiotics+ Hyper-CL lens * Treatment Group 2: Conventional treatment with topical Antibiotics
| Arm | Type | Receives |
|---|---|---|
| Conventional Antibiotics+ Hyper-CL™ lens | Experimental | Device: Hyper-CL™ lensConventional treatment with topical Antibiotics+ Hyper-CL™ lens |
| Conventional Antibiotics | No intervention | –Conventional treatment with topical Antibiotics |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is 18-86 years old
- Subject with Bacterial keratitis in one eye only
- Subject with Bacterial Keratitis of at least grade 2 score in Average length of infiltration and in Average length of epithelial defect (1mm or above)
- Best-corrected visual acuity of 6/60 or better in the uninvolved eye
- No prior antibiotic treatment for current Bacterial Keratitis
Key exclusion criteria (16 listed)
- Perforation or imminent perforation of cornea
- Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb
- Sign of inflammation in both eyes
- Severe itching suggesting viral infection or allergy reaction
- Subepithelial infiltrate suggesting viral infection
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™ lensUse of the Hyper-CL™ | Device | Conventional Antibiotics+ Hyper-CL™ lens |
Primary outcome
Change in Bacterial Keratitis severity score
Time frame: From date of randomization up to 14 days
Will be measured by Bacterial keratitis severity score (0-5). A low score is considered an improvement, a high score is considered worsening.
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 30 Nov 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyper-CL™ lens in people with Bacterial Keratitis, run by Eye-yon Medical at 2 sites in Israel.
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 6 inclusion and 16 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 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Change in Bacterial Keratitis severity score (time frame: From date of randomization up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2021.