Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00636363
First received: March 7, 2008
Last updated: December 7, 2011
Last verified: December 2011

March 7, 2008
December 7, 2011
March 2008
August 2008   (final data collection date for primary outcome measure)
  • Slit-lamp Findings > Grade 2 [ Time Frame: Over 4 visits for 3 month period ] [ Designated as safety issue: No ]
    eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.
  • Subjective Responses to Comfort Related Symptoms/Complaints [ Time Frame: Over 4 visits for the 3 month period ] [ Designated as safety issue: No ]
    Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
  • Contact Lens Deposits [ Time Frame: At each visit for 3 months ] [ Designated as safety issue: No ]
    Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.
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Complete list of historical versions of study NCT00636363 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution
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To the safety and efficacy of a Bausch & Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Contact Lens Solutions
  • Device: Bausch & Lomb Multipurpose Solution - Rub Care
    Daily care for contact lenses - rub care regimen
  • Device: Bausch & Lomb Multipurpose Solution - No Rub Care
    Daily care for contact lenses - no rub care regimen
  • Device: Ciba Vision Aquify Multipurpose Solution
    daily care for contact lenses
  • Experimental: Multipurpose Solution - Rub Care
    Bausch & Lomb Multipurpose Solution for use with contact lens care
    Intervention: Device: Bausch & Lomb Multipurpose Solution - Rub Care
  • Experimental: Multipurpose Solution - No Rub Care
    Bausch & Lomb Multipurpose Solution for use with contact lens care
    Intervention: Device: Bausch & Lomb Multipurpose Solution - No Rub Care
  • Active Comparator: Ciba Vision Aquify Multipurpose Solution
    Ciba Vision Aquify Multipurpose Solution for use with contact lens care
    Intervention: Device: Ciba Vision Aquify 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
541
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • subject is a habitual wearer of a silicone hydrogel or group IV contact lens
  • 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 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
United States
 
NCT00636363
554
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