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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2021

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.

Interventions

  • Device: Hyper-CL™ lens
    • Use of the Hyper-CL™

Arms, Groups and Cohorts

  • Experimental: Conventional Antibiotics+ Hyper-CL™ lens
    • Conventional treatment with topical Antibiotics+ Hyper-CL™ lens
  • No Intervention: Conventional Antibiotics
    • Conventional treatment with topical Antibiotics

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in Bacterial keratitis severity score.
    • Time Frame: From date of randomization up to 14 days
    • Will be measured by Bacterial keratitis severity score

Participating in This Clinical Trial

Inclusion Criteria

1. Subject is 18-86 years old

2. Subject with Bacterial keratitis in one eye only

Exclusion Criteria

1. Sign of inflammation in both eyes

2. Pregnancy

3. Other active ocular infection

4. Any infiltration suggesting other than bacterial infection e.g. parasite, fungal

5. Any other condition which in the opinion of the investigator would place the patient at undue risk for participation.

6. Participation in another clinical study within the past 30 days

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 86 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eye-yon Medical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Lori Michaeli, MA, 972722052400, lori@novatrials.com

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