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OpenTrials
Completed

NCT Number: NCT03845374

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

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.

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Key information

Conditions

Bacterial Keratitis

Age range

18 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Medical Center, Haifa, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyper-CL™ lens

Device

Use of the Hyper-CL™

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Eye-yon Medical

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 19, 2019
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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