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Swiss PACK-CXL Multicenter Trial for the Treatment of Infectious Keratitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717871
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Farhad Hafezi, University Hospital, Geneva

Brief Summary:
To assess the safety and efficacy of PACK-CXL (photoactivated chromophore for infectious keratitis cross-linking) as a firstline treatment for infectious corneal infiltrates and early corneal ulcers, and compare it to the current standard of care, antimicrobial therapy.

Condition or disease Intervention/treatment Phase
Keratitis; Infectious Disease (Manifestation) Device: PACK-CXL Drug: Cefazolin in combination with either tobramycin or gentamicin Drug: Cycloplegic agents (cyclopentolate 1% eye drops) Drug: Fluoroquinolones (Besifloxacin ; ciprofloxacin ; gatifloxacin ; levofloxacin ; moxifloxacin ; ofloxacin ) Drug: Corticosteroids (prednisolone acetate 0.5% or 1% eye drops) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Swiss PACK-CXL (Photoactivated Chromophore for Infectious Keratitis Cross-linking) Multicenter Trial for the Treatment of Infectious Keratitis
Study Start Date : March 2016
Actual Primary Completion Date : October 2020
Actual Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: Treatment (PACK-CXL)
Photoactivated chromophore for infectious keratitis-corneal cross-linking (PACK-CXL)
Device: PACK-CXL

Local anesthesia

- Oxybuprocaine or Tetracaine, 1 drop each, applied together, every 3 minutes, total of 3 times

Abrasio - Abrasio: 1 mm around the borders of the infiltrate/ulcer

Corneal scrape

Hypo-osmolaric riboflavin solution

- Apply one drop every 2 minutes for 20 minutes

UV-A irradiation

  • 3 mW/cm2 for 30 minutes or 9 mW/cm2 for 10 minutes, 18 mW/cm2 for 5 minutes, 30 mW/cm2 for 3 minutes all allowed (see paper Richoz et al)
  • Treatment diameter: use a irradiation diameter of 6 to 8 mm, keep the infiltrate/ulcus centered.

Additional postoperative treatment

  • Homatropin or Scopolamin, if anterior chamber reaction
  • Systemic NSAID/NSAR, if substantial pain
  • Do not use: topical or systemic steroids, topical NSAID/NSAR, paracetamol, vitamin A ointment, patching
Other Name: Corneal cross-linking

Active Comparator: Antimicrobial therapy

Control arm consists of standard topical antimicrobial therapy recommended for the treatment of microbial keratitis by the American Academy of Ophthalmology.

Initial empiric topical antibiotic therapy (eye drops or ocular ointment):

1a. Cefazolin (50mg/ml) in combination with either tobramycin (9-14mg/ml) or gentamicin (9-14mg/ml).

OR

1b. a Fluoroquinolones (Besifloxacin 6 mg/ml; ciprofloxacin 3 mg/ml; gatifloxacin 3 mg/ml; levofloxacin 15 mg/ml; moxifloxacin 5 mg/ml; ofloxacin 3 mg/ml)

2. Cycloplegic agents (cyclopentolate 1% eye drops): to decrease pain and synechia risk is at the physician discretion.

3. Corticosteroids (prednisolone acetate 0.5% or 1% eye drops): use of corticosteroids for patients included in the study only after complete closure of the epithelium

Drug: Cefazolin in combination with either tobramycin or gentamicin

Control arm consists of standard topical antimicrobial therapy recommended for the treatment of microbial keratitis by the American Academy of Ophthalmology.

Initial empiric topical antibiotic therapy (eye drops or ocular ointment):

1a. Cefazolin (50mg/ml) in combination with either tobramycin (9-14mg/ml) or gentamicin (9-14mg/ml).

Other Name: drug

Drug: Cycloplegic agents (cyclopentolate 1% eye drops)
Cycloplegic agents (cyclopentolate 1% eye drops): to decrease pain and synechia risk is at the physician discretion.

Drug: Fluoroquinolones (Besifloxacin ; ciprofloxacin ; gatifloxacin ; levofloxacin ; moxifloxacin ; ofloxacin )
Fluoroquinolones (Besifloxacin 6 mg/ml; ciprofloxacin 3 mg/ml; gatifloxacin 3 mg/ml; levofloxacin 15 mg/ml; moxifloxacin 5 mg/ml; ofloxacin 3 mg/ml)

Drug: Corticosteroids (prednisolone acetate 0.5% or 1% eye drops)
Corticosteroids (prednisolone acetate 0.5% or 1% eye drops): use of corticosteroids for patients included in the study only after complete closure of the epithelium




Primary Outcome Measures :
  1. Time to re-epithelialization of the corneal surface [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Time from treatment to discharge of the patient [ Time Frame: 28 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient exhibit clinical signs of corneal infiltrate or beginning corneal ulcer on at least one eye, of suspected bacterial, fungal or mixed (bacterial and fungal) origin.
  • Infiltrates and early ulcers up to a maximum 2mm in diameter; may lie close to the corneal limbus, but at a minimal distance of 2mm from central cornea.
  • Infiltrates and early ulcer depth of a maximum of 300 μm, assessed by either OCT or Scheimpflug imaging
  • All lesions must show an open epithelium with fluorescein positive staining
  • No previous antibiotic/antifungal treatment OR at least no antibiotic/antifungal treatment for a minimum of 48 hours from last treatment
  • Provide signed and dated patient consent form
  • Patient willing to comply with all study procedures and be available for the duration of the study
  • Male or female, >18 years of age. No children or adolescents of 18 years and less of age will be included in this study.

Exclusion Criteria:

  • Lesion/infiltrate involving the central 2mm diameter of the cornea
  • Suspicion of non-infectious keratitis, viral or acanthamoeba keratitis or sterile infiltrate.
  • Closed epithelium over the lesion
  • Pachymetry of less than 400 microns at the thinnest point.
  • Patients who cannot participate in the treatment or be monitored with frequent clinician controls as required in the study protocol.
  • Corneal perforation
  • Descemetocele
  • Pregnancy or breastfeeding
  • Active corneal herpetic disease
  • Systemic treatment involving steroids
  • Immunosuppressed/immune-compromised patients
  • Patients with diagnosed eczema (or atopic dermatitis)
  • Previous keratoplasty
  • Patients with monocular vision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717871


Locations
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Switzerland
University of Geneva
Geneva, GE, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Farhad Hafezi, MD, PhD fhafezi@elza-institute.com
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Farhad Hafezi, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02717871    
Other Study ID Numbers: CER 11-198
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Farhad Hafezi, University Hospital, Geneva:
Collagen cross-linking, PACK-CXL, infectious keratitis, CXL.
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Keratitis
Corneal Diseases
Eye Diseases
Moxifloxacin
Ciprofloxacin
Levofloxacin
Ofloxacin
Gentamicins
Cefazolin
Tobramycin
Gatifloxacin
Besifloxacin
Fluoroquinolones
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Ophthalmic Solutions
Prednisolone hemisuccinate
Prednisolone phosphate
Cyclopentolate
Mydriatics
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs