A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution

This study has been completed.
Sponsor:
Information provided by:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01024751
First received: November 30, 2009
Last updated: August 11, 2011
Last verified: July 2011
  Purpose

The objective of this study is to evaluate the clinical performance of Bausch & Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses.


Condition Intervention
Ocular Discomfort
Device: Bausch & Lomb Multi-Purpose Solution
Device: Ciba's Multi-Purpose Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Comfort-related Symptoms/Complaints [ Time Frame: At dispensing visit and each follow-up visit at week 2 and week 4. ] [ Designated as safety issue: No ]
    Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.


Secondary Outcome Measures:
  • Slit Lamp Findings [ Time Frame: Over all visits for 1 month ] [ Designated as safety issue: Yes ]
    Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.


Enrollment: 312
Study Start Date: November 2009
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bausch & Lomb Multi-Purpose Solution
Multi-Purpose Solution to be used for disinfecting contact lenses.
Device: Bausch & Lomb Multi-Purpose Solution
Lens care product for disinfecting lenses on a daily basis.
Active Comparator: Ciba's Multi-Purpose Solution
Multi-Purpose Solution to be used for disinfecting contact lenses.
Device: Ciba's Multi-Purpose Solution
Lens care product for disinfecting lenses on a daily basis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
  • Participants must habitually use a lens care product for lens cleaning, disinfecting, and storage.
  • Participants must wear a lens in each eye and each lens must be of the same manufacture and brand.
  • Participants must agree to wear study lenses on a daily wear basis.
  • Participants must be able and willing to comply with all treatment and follow-up/study procedures.

Exclusion Criteria:

  • Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
  • Participants with any systemic disease affecting ocular health.
  • Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Participants who have had any corneal surgery (eg, refractive surgery).
  • Participants who are allergic to any component in the study care products.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024751

Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Mohinder Merchea, OD, PhD, MBA, Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01024751     History of Changes
Other Study ID Numbers: 636
Study First Received: November 30, 2009
Results First Received: June 16, 2011
Last Updated: August 11, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014