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Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify 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: NCT00636363
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : April 8, 2011
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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Brief Summary:
To the safety and efficacy of a Bausch & Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution

Condition or disease Intervention/treatment Phase
Contact Lens Solutions Device: Bausch & Lomb Multipurpose Solution - Rub Care Device: Bausch & Lomb Multipurpose Solution - No Rub Care Device: Ciba Vision Aquify Multipurpose Solution Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 541 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Study Start Date : March 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008
Arms and Interventions
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Arm Intervention/treatment
Experimental: Multipurpose Solution - Rub Care
Bausch & Lomb Multipurpose Solution for use with contact lens care
 Device: Bausch & Lomb Multipurpose Solution - Rub Care
Daily care for contact lenses - rub care regimen
Experimental: Multipurpose Solution - No Rub Care
Bausch & Lomb Multipurpose Solution for use with contact lens care
 Device: Bausch & Lomb Multipurpose Solution - No Rub Care
Daily care for contact lenses - no rub care regimen
Active Comparator: Ciba Vision Aquify Multipurpose Solution
Ciba Vision Aquify Multipurpose Solution for use with contact lens care
 Device: Ciba Vision Aquify Multipurpose Solution
daily care for contact lenses


Outcome Measures
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Primary Outcome Measures :
  1. Slit-lamp Findings > Grade 2 [ Time Frame: Over 4 visits for 3 month period ]
    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.

  2. Subjective Responses to Comfort Related Symptoms/Complaints [ Time Frame: Over 4 visits for the 3 month period ]
    Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.

  3. Contact Lens Deposits [ Time Frame: At each visit for 3 months ]
    Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.


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

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
Contacts and Locations
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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): NCT00636363


Locations
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United States, New York
Place Eye Care
LeRoy, New York, United States, 14482
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Mohinder Merchea, OD, PhD Bausch & Lomb Incorporated
More Information
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00636363    
Other Study ID Numbers: 554
First Posted: March 14, 2008    Key Record Dates
Results First Posted: April 8, 2011
Last Update Posted: March 24, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Pharmaceutical Solutions