A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution

The objective of this study is to evaluate the clinical performance of Bausch & Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses.

Study Overview

• Status: Completed
• Conditions: Ocular Discomfort
• Intervention / Treatment: Device: Bausch & Lomb Multi-Purpose Solution; Device: Ciba's Multi-Purpose Solution

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch & Lomb

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:

• Participants must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
• Participants must habitually use a lens care product for lens cleaning, disinfecting, and storage.
• Participants must wear a lens in each eye and each lens must be of the same manufacture and brand.
• Participants must agree to wear study lenses on a daily wear basis.
• Participants must be able and willing to comply with all treatment and follow-up/study procedures.

Exclusion Criteria:

• Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
• Participants with any systemic disease affecting ocular health.
• Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Participants who have had any corneal surgery (eg, refractive surgery).
• Participants who are allergic to any component in the study care products.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bausch & Lomb Multi-Purpose Solution; Multi-Purpose Solution to be used for disinfecting contact lenses.	Device: Bausch & Lomb Multi-Purpose Solution; Lens care product for disinfecting lenses on a daily basis.
Active Comparator: Ciba's Multi-Purpose Solution; Multi-Purpose Solution to be used for disinfecting contact lenses.	Device: Ciba's Multi-Purpose Solution; Lens care product for disinfecting lenses on a daily basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort-related Symptoms/Complaints	Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.	At dispensing visit and each follow-up visit at week 2 and week 4.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit Lamp Findings	Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.	Over all visits for 1 month

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimate): December 3, 2009

Study Record Updates

• Last Update Posted (Estimate): August 15, 2011
• Last Update Submitted That Met QC Criteria: August 11, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: 636