Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution

Product Performance of Bausch & Lomb Multi-Purpose Solution Compared to Alcon Opti-Free Replenish Multi-Purpose Solution When Used With Silicone Hydrogel Contact Lenses Worn on a Daily Wear Basis

To evaluate the product performance of a Bausch & Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution

Study Overview

• Status: Completed
• Conditions: Adverse Effect of Contact Lens Solution
• Intervention / Treatment: Device: Bausch & Lomb Multipurpose Solution; Device: Alcon OptiFree Replenish Multipurpose Solution

• Study Type: Interventional
• Enrollment (Actual): 361
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Johor Bahru
    • Jalan Kuning, Tamn Pelangi, Johor Bahru, Malaysia, 80400
      • Laser Focus Sdn Bhd, Vision Correction Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects are adapted wearers of silicone hydrogel 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 a monovision, multifocal or toric contact lenses
• Any grade 2 or greater slit lamp findings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B&L Multipurpose solution; Bausch & Lomb Multipurpose Contact Lens Solution	Device: Bausch & Lomb Multipurpose Solution; daily care of contact lenses
Active Comparator: Alcon Multipurpose Solution; Alcon OptiFree Replenish Multipurpose Contact Lens Solution	Device: Alcon OptiFree Replenish Multipurpose Solution; daily care for contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Assessment of Comfort and Cleanliness	Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms and Complaints	Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score.	2 weeks
Graded Slit Lamp Findings > Grade 2	Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.	2 week follow-up visit

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Mohinder Merchea, OD, PhD, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: March 7, 2008
• First Submitted That Met QC Criteria: March 7, 2008
• First Posted (Estimate): March 14, 2008

Study Record Updates

• Last Update Posted (Estimate): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: 562