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Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution

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: NCT00636194
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : February 15, 2011
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Tracking Information
First Submitted Date  ICMJE March 7, 2008
First Posted Date  ICMJE March 14, 2008
Results First Submitted Date  ICMJE December 14, 2010
Results First Posted Date  ICMJE February 15, 2011
Last Update Posted Date December 13, 2011
Study Start Date  ICMJE February 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2011)
Subjective Assessment of Comfort and Cleanliness [ Time Frame: 7 days ]
Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00636194 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2011)
  • Symptoms and Complaints [ Time Frame: 2 weeks ]
    Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score.
  • Graded Slit Lamp Findings > Grade 2 [ Time Frame: 2 week follow-up visit ]
    Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.
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 Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution
Official Title  ICMJE Product Performance of Bausch & Lomb Multi-Purpose Solution Compared to Alcon Opti-Free Replenish Multi-Purpose Solution When Used With Silicone Hydrogel Contact Lenses Worn on a Daily Wear Basis
Brief Summary To evaluate the product performance of a Bausch & Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Adverse Effect of Contact Lens Solution
Intervention  ICMJE
  • Device: Bausch & Lomb Multipurpose Solution
    daily care of contact lenses
  • Device: Alcon OptiFree Replenish Multipurpose Solution
    daily care for contact lenses
Study Arms  ICMJE
  • Experimental: B&L Multipurpose solution
    Bausch & Lomb Multipurpose Contact Lens Solution
    Intervention: Device: Bausch & Lomb Multipurpose Solution
  • Active Comparator: Alcon Multipurpose Solution
    Alcon OptiFree Replenish Multipurpose Contact Lens Solution
    Intervention: Device: Alcon OptiFree Replenish Multipurpose 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: January 19, 2011)
361
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects are adapted wearers of silicone hydrogel contact lenses
  • VA correctable to 0.3 LogMAR or better (driving vision)
  • Clear central cornea
  • Subject uses a lens care system on a regular basis

Exclusion Criteria:

  • Systemic disease affecting ocular health
  • Using systemic or topical medications
  • wear a monovision, multifocal or toric contact lenses
  • Any grade 2 or greater slit lamp findings
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00636194
Other Study ID Numbers  ICMJE 562
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch & Lomb Incorporated
Study Sponsor  ICMJE Bausch & Lomb Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mohinder Merchea, OD, PhD Bausch & Lomb Incorporated
PRS Account Bausch & Lomb Incorporated
Verification Date December 2011

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