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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014