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

Not Applicable

Completed

• Conditions: Contact Lens Solutions

• 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

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