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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:
ClinicalTrials.gov Identifier:
NCT00636363
First Posted: March 14, 2008
Last Update Posted: March 24, 2015
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.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00636363     History of Changes
Other Study ID Numbers: 554
First Submitted: March 7, 2008
First Posted: March 14, 2008
Results First Submitted: February 3, 2011
Results First Posted: April 8, 2011
Last Update Posted: March 24, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Pharmaceutical Solutions