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

Not Applicable

Completed

Interventions: Device: Bausch & Lomb Multi-Purpose Solution
Device: Ciba's Multi-Purpose Solution

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Bausch & Lomb Multi-Purpose Solution	Bausch & Lomb Multi-Purpose Solution	Multi-Purpose Solution to be used for disinfecting contact lenses.
Ciba's Multi-Purpose Solution	Ciba's Multi-Purpose Solution	Multi-Purpose Solution to be used for disinfecting contact lenses.

Primary Outcome Measures

Name	Time	Method
Comfort-related Symptoms/Complaints	At dispensing visit and each follow-up visit at week 2 and week 4.	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.

Secondary Outcome Measures

Name	Time	Method
Slit Lamp Findings	Over all visits for 1 month	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.