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
1 other identifier
interventional
361
1 country
1
Brief Summary
To evaluate the product performance of a Bausch \& Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 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
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 7, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
February 15, 2011
CompletedDecember 13, 2011
December 1, 2011
29 days
March 7, 2008
December 14, 2010
December 7, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Symptoms and Complaints
2 weeks
Graded Slit Lamp Findings > Grade 2
2 week follow-up visit
Study Arms (2)
B&L Multipurpose solution
EXPERIMENTALBausch \& Lomb Multipurpose Contact Lens Solution
Alcon Multipurpose Solution
ACTIVE COMPARATORAlcon OptiFree Replenish Multipurpose Contact Lens Solution
Interventions
daily care for contact lenses
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laser Focus Sdn Bhd, Vision Correction Centre
Jalan Kuning, Tamn Pelangi, Johor Bahru, 80400, Malaysia
Results Point of Contact
- Title
- Robert Steffen OD
- Organization
- Bausch & Lomb
Study Officials
- STUDY DIRECTOR
Mohinder Merchea, OD, PhD
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2008
First Posted
March 14, 2008
Study Start
February 1, 2008
Primary Completion
March 1, 2008
Study Completion
April 1, 2008
Last Updated
December 13, 2011
Results First Posted
February 15, 2011
Record last verified: 2011-12