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

Not Applicable

Completed

• Conditions: Comfort
• Interventions: 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.

• Registration Number: NCT00659815
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-12
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-16
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2010-09-07
• Results First Submitted QC: 2010-10-18
• Results First Posted: 2010-11-15
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ReNu in Currently Marketed Bottle	Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.	Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.
ReNu in Clear Resin Bottle	Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.	Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.

Primary Outcome Measures

Name	Time	Method
Comfort	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.
Slit Lamp Findings	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.
Lens Deposits	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.

Trial Locations

Locations (1)

James Ferrari, OD; 🇺🇸 Rochester, New York, United States