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

Ocular Discomfort Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024751
• Other study ID #: 636
• Status: Completed
• Phase: N/A
• First received: November 30, 2009
• Last updated: August 11, 2011
• Start date: November 2009
• Est. completion date: February 2010

Study information

• Verified date: July 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ocular Discomfort

Intervention

Device:
• Bausch & Lomb Multi-Purpose Solution
Lens care product for disinfecting lenses on a daily basis.
• Ciba's Multi-Purpose Solution
Lens care product for disinfecting lenses on a daily basis.

Locations

Country	Name	City	State
United States	Bausch & Lomb	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	Yes