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Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a New Packaging Configuration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00659815
First received: April 12, 2008
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  Purpose

The objective of the study is to evaluate the product performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration


Condition Intervention
Comfort
 Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.
Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a Clear Polyethylene Terephthalate (PET) Bottle.

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Comfort [ Time Frame: Over-all follow-up visits from baseline to 1 month ] [ Designated as safety issue: No ]
    Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating.

  • Slit Lamp Findings [ Time Frame: Over-all follow-up visits from baseline to1 month ] [ Designated as safety issue: No ]
    Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.

  • Lens Deposits [ Time Frame: Over-all study visits, baseline to 1-month ] [ Designated as safety issue: No ]
    Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.


Enrollment: 312
Study Start Date: March 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ReNu in Currently Marketed Bottle
Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.
 Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.
Daily care for contact lenses.
Experimental: ReNu in Clear Resin Bottle
Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.
 Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.
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 planned replacement soft contact lenses
  • 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: NCT00659815

Locations
United States, New York
James Ferrari, OD
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Gerard Cairns, PhD, MCOptom Bausch & Lomb Incorporated
Principal Investigator: James Ferrari, OD James Ferrari, OD
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00659815     History of Changes
Other Study ID Numbers: 549
Study First Received: April 12, 2008
Results First Received: September 7, 2010
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013