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Mucin Balls and Corneal Inflammation Events

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01437319
First Posted: September 20, 2011
Last Update Posted: February 25, 2016
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.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
  Purpose
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.

Condition Intervention Phase
Corneal Inflammation Corneal Infiltrative Events Device: lotrafilcon A Device: comfilcon A Device: balafilcon A Other: etafilcon A Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Corneal Infiltrate Events - Phase I [ Time Frame: 1-Month Follow-up ]
    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 ]
    The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.


Enrollment: 289
Study Start Date: September 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: lotrafilcon A
To be used during run-in phase only.
Device: comfilcon A
To be assigned at randomization at phase 2 only.
Other: etafilcon A
Assigned to Neophytes during Phase I for a 2-week period
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.
Device: lotrafilcon A
To be used during run-in phase 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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT01437319


Locations
United States, Ohio
Beachwood, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01437319     History of Changes
Other Study ID Numbers: CR-005016
First Submitted: September 16, 2011
First Posted: September 20, 2011
Results First Submitted: November 16, 2015
Results First Posted: February 25, 2016
Last Update Posted: February 25, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Inflammation
Keratitis
Pathologic Processes
Corneal Diseases
Eye Diseases