Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a New Packaging Configuration
1 other identifier
interventional
312
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 12, 2008
CompletedFirst Posted
Study publicly available on registry
April 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
November 15, 2010
CompletedDecember 12, 2011
December 1, 2011
2 months
April 12, 2008
September 7, 2010
December 7, 2011
Conditions
Outcome Measures
Primary Outcomes (3)
Comfort
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.
Over-all follow-up visits from baseline to 1 month
Slit Lamp Findings
Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.
Over-all follow-up visits from baseline to1 month
Lens Deposits
Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.
Over-all study visits, baseline to 1-month
Study Arms (2)
ReNu in Currently Marketed Bottle
ACTIVE COMPARATORBausch \& Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.
ReNu in Clear Resin Bottle
EXPERIMENTALBausch \& Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.
Interventions
Daily care for contact lenses.
Daily care for contact lenses
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
James Ferrari, OD
Rochester, New York, 14609, United States
Results Point of Contact
- Title
- Gerard Cairns
- Organization
- Bausch & Lomb Incorporated
Study Officials
- STUDY DIRECTOR
Gerard Cairns, PhD, MCOptom
Bausch & Lomb Incorporated
- PRINCIPAL INVESTIGATOR
James Ferrari, OD
James Ferrari, OD
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2008
First Posted
April 16, 2008
Study Start
March 1, 2008
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
December 12, 2011
Results First Posted
November 15, 2010
Record last verified: 2011-12