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A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution

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ClinicalTrials.gov Identifier: NCT01024751
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : August 11, 2011
Last Update Posted : August 15, 2011
Sponsor:
Information provided by:
Bausch & Lomb Incorporated

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE December 3, 2009
Results First Submitted Date  ICMJE June 16, 2011
Results First Posted Date  ICMJE August 11, 2011
Last Update Posted Date August 15, 2011
Study Start Date  ICMJE November 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
Comfort-related Symptoms/Complaints [ Time Frame: At dispensing visit and each follow-up visit at week 2 and week 4. ]
Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
Subject comfort-related symptoms/complaints [ Time Frame: At dispensing visit and each follow-up visit at week 2 and week 4. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
Slit Lamp Findings [ Time Frame: Over all visits for 1 month ]
Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution
Official Title  ICMJE A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution
Brief Summary The objective of this study is to evaluate the clinical performance of Bausch & Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Ocular Discomfort
Intervention  ICMJE
  • Device: Bausch & Lomb Multi-Purpose Solution
    Lens care product for disinfecting lenses on a daily basis.
  • Device: Ciba's Multi-Purpose Solution
    Lens care product for disinfecting lenses on a daily basis.
Study Arms  ICMJE
  • Experimental: Bausch & Lomb Multi-Purpose Solution
    Multi-Purpose Solution to be used for disinfecting contact lenses.
    Intervention: Device: Bausch & Lomb Multi-Purpose Solution
  • Active Comparator: Ciba's Multi-Purpose Solution
    Multi-Purpose Solution to be used for disinfecting contact lenses.
    Intervention: Device: Ciba's Multi-Purpose Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2011)
312
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2009)
320
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
  • Participants must habitually use a lens care product for lens cleaning, disinfecting, and storage.
  • Participants must wear a lens in each eye and each lens must be of the same manufacture and brand.
  • Participants must agree to wear study lenses on a daily wear basis.
  • Participants must be able and willing to comply with all treatment and follow-up/study procedures.

Exclusion Criteria:

  • Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
  • Participants with any systemic disease affecting ocular health.
  • Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Participants who have had any corneal surgery (eg, refractive surgery).
  • Participants who are allergic to any component in the study care products.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01024751
Other Study ID Numbers  ICMJE 636
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohinder Merchea, OD, PhD, MBA, Bausch & Lomb Incorporated
Study Sponsor  ICMJE Bausch & Lomb Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bausch & Lomb Incorporated
Verification Date July 2011

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