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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
History of Changes
  Purpose

To the safety and efficacy of a Bausch & Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution


Condition Intervention
Contact Lens Solutions
 Device: Bausch & Lomb Multipurpose Solution - Rub Care
Device: Bausch & Lomb Multipurpose Solution - No Rub Care
Device: Ciba Vision Aquify Multipurpose Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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.


Enrollment: 541
Study Start Date: March 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636363

Locations
United States, New York
Place Eye Care
LeRoy, New York, United States, 14482
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Mohinder Merchea, OD, PhD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00636363     History of Changes
Other Study ID Numbers: 554
Study First Received: March 7, 2008
Results First Received: February 3, 2011
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 22, 2013