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
  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
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: 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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014