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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Ocular Discomfort	Device: Bausch & Lomb Multi-Purpose Solution; Device: Ciba's Multi-Purpose Solution	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	312 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Supportive Care
Official Title:	A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution
Study Start Date :	November 2009
Actual Primary Completion Date :	January 2010
Actual Study Completion Date :	February 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

1. Comfort-related Symptoms/Complaints [ Time Frame: 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 :

1. Slit Lamp Findings [ Time Frame: 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Bausch & Lomb Incorporated

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mohinder Merchea, OD, PhD, MBA, Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT01024751 History of Changes
Other Study ID Numbers:	636
First Posted:	December 3, 2009
Results First Posted:	August 11, 2011
Last Update Posted:	August 15, 2011
Last Verified:	July 2011

Additional relevant MeSH terms:

Pharmaceutical Solutions