Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00636194
First received: March 7, 2008
Last updated: December 7, 2011
Last verified: December 2011

March 7, 2008
December 7, 2011
February 2008
March 2008   (final data collection date for primary outcome measure)
Subjective Assessment of Comfort and Cleanliness [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.
Not Provided
Complete list of historical versions of study NCT00636194 on ClinicalTrials.gov Archive Site
  • Symptoms and Complaints [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution
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

To evaluate the product performance of a Bausch & Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Adverse Effect of Contact Lens Solution
  • Device: Bausch & Lomb Multipurpose Solution
    daily care of contact lenses
  • Device: Alcon OptiFree Replenish Multipurpose Solution
    daily care for contact lenses
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
361
April 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
NCT00636194
562
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Mohinder Merchea, OD, PhD Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
December 2011

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