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

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

Study Overview

• Status: Completed
• Conditions: Contact Lens Solutions
• Intervention / Treatment: Device: Bausch & Lomb Multipurpose Solution - Rub Care; Device: Bausch & Lomb Multipurpose Solution - No Rub Care; Device: Ciba Vision Aquify Multipurpose Solution

• Study Type: Interventional
• Enrollment (Actual): 541
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • LeRoy, New York, United States, 14482
      • Place Eye Care

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:

• 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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multipurpose Solution - Rub Care; Bausch & Lomb Multipurpose Solution for use with contact lens care	Device: Bausch & Lomb Multipurpose Solution - Rub Care; Daily care for contact lenses - rub care regimen
Experimental: Multipurpose Solution - No Rub Care; Bausch & Lomb Multipurpose Solution for use with contact lens care	Device: Bausch & Lomb Multipurpose Solution - No Rub Care; Daily care for contact lenses - no rub care regimen
Active Comparator: Ciba Vision Aquify Multipurpose Solution; Ciba Vision Aquify Multipurpose Solution for use with contact lens care	Device: Ciba Vision Aquify Multipurpose Solution; daily care for contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit-lamp Findings > Grade 2	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.	Over 4 visits for 3 month period
Subjective Responses to Comfort Related Symptoms/Complaints	Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.	Over 4 visits for the 3 month period
Contact Lens Deposits	Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.	At each visit for 3 months

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: March 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 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): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: 554