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

Study Overview
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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.

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

Conditions
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Bacterial Keratitis

Intervention / Treatment
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* Device: Hyper-CL™ lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Antibiotics+ Hyper-CL™ lens<br>Conventional treatment with topical Antibiotics+ Hyper-CL™ lens | Device: Hyper-CL™ lens<br>* Use of the Hyper-CL™<br>|
| No Intervention: Conventional Antibiotics<br>Conventional treatment with topical Antibiotics | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From date of randomization up to 14 days |