A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution - Full Text View

Purpose

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	Intervention
Ocular Discomfort	Device: Bausch & Lomb Multi-Purpose Solution Device: Ciba's Multi-Purpose Solution


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care
Official Title:	A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:

Comfort-related Symptoms/Complaints [ Time Frame: At dispensing visit and each follow-up visit at week 2 and week 4. ] [ Designated as safety issue: No ]
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:

Slit Lamp Findings [ Time Frame: Over all visits for 1 month ] [ Designated as safety issue: Yes ]
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.


Enrollment:	312
Study Start Date:	November 2009
Study Completion Date:	February 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024751

Locations


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

Sponsors and Collaborators

Bausch & Lomb Incorporated

More Information

No publications provided


Responsible Party:	Mohinder Merchea, OD, PhD, MBA, Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT01024751 History of Changes
Other Study ID Numbers:	636
Study First Received:	November 30, 2009
Results First Received:	June 16, 2011
Last Updated:	August 11, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Pharmaceutical Solutions Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015