Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution

Not Applicable

Completed

• Conditions: Contact Lens Solutions
• Interventions: Device: Bausch & Lomb Multipurpose Solution - No Rub Care; Device: Bausch & Lomb Multipurpose Solution - Rub Care; Device: Ciba Vision Aquify Multipurpose Solution

• Registration Number: NCT00636363
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

To the safety and efficacy of a Bausch \& Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-14
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2011-02-03
• Results First Submitted QC: 2011-03-11
• Results First Posted: 2011-04-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 541

Inclusion Criteria

• subject is a habitual wearer of a silicone hydrogel or group IV contact lens
• 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
Multipurpose Solution - No Rub Care	Bausch & Lomb Multipurpose Solution - No Rub Care	Bausch \& Lomb Multipurpose Solution for use with contact lens care
Multipurpose Solution - Rub Care	Bausch & Lomb Multipurpose Solution - Rub Care	Bausch \& Lomb Multipurpose Solution for use with contact lens care
Ciba Vision Aquify Multipurpose Solution	Ciba Vision Aquify Multipurpose Solution	Ciba Vision Aquify Multipurpose Solution for use with contact lens care

Primary Outcome Measures

Name	Time	Method
Slit-lamp Findings > Grade 2	Over 4 visits for 3 month period	eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.
Subjective Responses to Comfort Related Symptoms/Complaints	Over 4 visits for the 3 month period	Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Contact Lens Deposits	At each visit for 3 months	Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.

Trial Locations

Locations (1)

Place Eye Care; 🇺🇸 LeRoy, New York, United States