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

Comfort Clinical Trial

Official title:

Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a Clear Polyethylene Terephthalate (PET) Bottle.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659815
• Other study ID #: 549
• Status: Completed
• Phase: N/A
• First received: April 12, 2008
• Last updated: December 7, 2011
• Start date: March 2008
• Est. completion date: May 2008

Study information

• Verified date: December 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Comfort

Intervention

Device:
• Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.
Daily care for contact lenses.
• Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.
Daily care for contact lenses

Locations

Country	Name	City	State
United States	James Ferrari, OD	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No