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Mucin Balls and Corneal Inflammation Events

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01437319
First received: September 16, 2011
Last updated: January 28, 2016
Last verified: January 2016

September 16, 2011
January 28, 2016
September 2011
February 2014   (final data collection date for primary outcome measure)
  • Corneal Infiltrate Events - Phase I [ Time Frame: 1-Month Follow-up ] [ Designated as safety issue: No ]
    The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
  • Corneal Infiltrate Event- Phase II [ Time Frame: 12-Month Follow-up ] [ Designated as safety issue: No ]
    The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
  • Corneal Inflammatory Events [ Time Frame: Post Randomization at 7 days ] [ Designated as safety issue: No ]
    The presence and number of Corneal Inflammatory Events at each visit.
  • Corneal Inflammatory Events [ Time Frame: Post Randomization at 1 month ] [ Designated as safety issue: No ]
    The presence and number of Corneal Inflammatory Events at each visit.
  • Corneal Inflammatory Events [ Time Frame: Post Randomization at 4 months ] [ Designated as safety issue: No ]
    The presence and number of Corneal Inflammatory Events at each visit.
  • Corneal Inflammatory Events [ Time Frame: Post Randomization at 8 months ] [ Designated as safety issue: No ]
    The presence and number of Corneal Inflammatory Events at each visit.
  • Corneal Inflammatory Events [ Time Frame: Post Randomization at 12 months ] [ Designated as safety issue: No ]
    The presence and number of Corneal Inflammatory Events at each visit.
Complete list of historical versions of study NCT01437319 on ClinicalTrials.gov Archive Site
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Mucin Balls and Corneal Inflammation Events
Not Provided
The purpose of this study is to determine if the formation of mucin balls is a marker for protection from inflammatory events to the cornea and if mucin balls play a role in protection during extended contact lens wear.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Corneal Inflammation
  • Corneal Infiltrative Events
  • Device: lotrafilcon A
    To be used during run-in phase only.
  • Device: comfilcon A
    To be assigned at randomization at phase 2 only.
  • Device: balafilcon A
    To be assigned at randomization during phase 2 only.
  • Other: etafilcon A
    Assigned to Neophytes during Phase I for a 2-week period
  • Active Comparator: lotrafilcon A, comfilcon A
    All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
    Interventions:
    • Device: lotrafilcon A
    • Device: comfilcon A
    • Other: etafilcon A
  • Active Comparator: lotrafilcon A, balafilcon A
    All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
    Interventions:
    • Device: lotrafilcon A
    • Device: balafilcon A
    • Other: etafilcon A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
289
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 18 years
  • Free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis (via a large, >1mm central deep stromal scar) are not allowed. However, evidence of past Contact Lens-Induces Peripheral Ulcer (CLPU) will be allowed so long as no more then three such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the subject for a subsequent Corneal Infiltrate Event (CIE).
  • Correctable vision to 20/25 or better in each eye with spectacles. Amblyopia will be excluded.
  • Flat and steep corneal curvatures from keratometry readings must be between 39.00 and 48.50 D, respectively.
  • Own or agree to purchase a pair of spectacles that can be worn when lenses are removed or in cases of ocular discomfort or emergency.
  • Correctable vision to 20/30 or better at distance with dispensed contact lenses.

Exclusion Criteria:

  • Use/wear of rigid gas permeable lenses within the last 30 days or Poly (methyl methacrylate) (PMMA) lenses within the last 3 months.
  • Immunocompromising disease or insulin dependent diabetes or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during extended wear.
  • Chronic use of systemic corticosteroids (with the exception of corticosteroid inhalers) or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
  • Ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
  • Use of any ocular medications in the last 2 weeks.
  • Less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales.
  • Currently pregnant or lactating.
  • Smoker
  • Swimming routine of more than twice per month.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01437319
CR-005016
Not Provided
Not Provided
Not Provided
Johnson & Johnson Vision Care, Inc.
Johnson & Johnson Vision Care, Inc.
Not Provided
Not Provided
Johnson & Johnson Vision Care, Inc.
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP