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

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.
 
ClinicalTrials.gov Identifier: NCT00659815
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : November 15, 2010
Last Update Posted : December 12, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
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. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a Clear Polyethylene Terephthalate (PET) Bottle.
Study Start Date : March 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Comfort [ Time Frame: Over-all follow-up visits from baseline to 1 month ]
    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.

  2. Slit Lamp Findings [ Time Frame: Over-all follow-up visits from baseline to1 month ]
    Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.

  3. Lens Deposits [ Time Frame: Over-all study visits, baseline to 1-month ]
    Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00659815


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

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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00659815    
Other Study ID Numbers: 549
First Posted: April 16, 2008    Key Record Dates
Results First Posted: November 15, 2010
Last Update Posted: December 12, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
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Pharmaceutical Solutions