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

Not Applicable

Completed

• Conditions: Adverse Effect of Contact Lens Solution
• Interventions: Device: Bausch & Lomb Multipurpose Solution; Device: Alcon OptiFree Replenish Multipurpose Solution

• Registration Number: NCT00636194
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-03
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-14
• Study Completion: 2008-04
• Results First Submitted: 2010-12-14
• Results First Submitted QC: 2011-01-19
• Results First Posted: 2011-02-15
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B&L Multipurpose solution	Bausch & Lomb Multipurpose Solution	Bausch \& Lomb Multipurpose Contact Lens Solution
Alcon Multipurpose Solution	Alcon OptiFree Replenish Multipurpose Solution	Alcon OptiFree Replenish Multipurpose Contact Lens Solution

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Symptoms and Complaints	2 weeks	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.
Graded Slit Lamp Findings > Grade 2	2 week follow-up visit	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.

Trial Locations

Locations (1)

Laser Focus Sdn Bhd, Vision Correction Centre; 🇲🇾 Jalan Kuning, Tamn Pelangi, Johor Bahru, Malaysia