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Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis

NCT ID: NCT03845374

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-13

Study Completion Date

2021-01-11

Brief Summary

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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

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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

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Bacterial Keratitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Antibiotics+ Hyper-CL™ lens

Conventional treatment with topical Antibiotics+ Hyper-CL™ lens

Group Type EXPERIMENTAL

Hyper-CL™ lens

Intervention Type DEVICE

Use of the Hyper-CL™

Conventional Antibiotics

Conventional treatment with topical Antibiotics

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyper-CL™ lens

Use of the Hyper-CL™

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject is 18-86 years old
2. Subject with Bacterial keratitis in one eye only
3. 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)
4. Best-corrected visual acuity of 6/60 or better in the uninvolved eye
5. No prior antibiotic treatment for current Bacterial Keratitis
6. 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. Perforation or imminent perforation of cornea
2. Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb
3. Sign of inflammation in both eyes
4. Severe itching suggesting viral infection or allergy reaction
5. Subepithelial infiltrate suggesting viral infection
6. Dendrite like ulcer or suspecting of Herpes keratitis
7. Previous penetrating keratoplasty
8. No light perception in the affected eye
9. Pregnancy
10. Other active ocular infection
11. Any infiltration suggesting other than bacterial infection e.g. parasite, fungal
12. Any corneal transplant
13. Post refractive surgery
14. Corneal inlays
15. Any other condition which in the opinion of the investigator would place the patient at undue risk for participation.
16. Participation in another clinical study within the past 30 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye-yon Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status

Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CLI-H004

Identifier Type: -

Identifier Source: org_study_id