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

NCT01024751 | Completed Results

• 1 other identifier: 636
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Discomfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Slit Lamp Findings

  Over all visits for 1 month

Study Arms (2)

Bausch & Lomb Multi-Purpose Solution

EXPERIMENTAL

Multi-Purpose Solution to be used for disinfecting contact lenses.

Device: Bausch & Lomb Multi-Purpose Solution

Ciba's Multi-Purpose Solution

ACTIVE COMPARATOR

Multi-Purpose Solution to be used for disinfecting contact lenses.

Device: Ciba's Multi-Purpose Solution

Interventions

Bausch & Lomb Multi-Purpose Solution DEVICE

Lens care product for disinfecting lenses on a daily basis.

Bausch & Lomb Multi-Purpose Solution

Ciba's Multi-Purpose Solution DEVICE

Lens care product for disinfecting lenses on a daily basis.

Ciba's Multi-Purpose Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb

Rochester, New York, 14609, United States

Location

Results Point of Contact

• Title: William Reindel, OD, MS
• Organization: Bausch & Lomb Incorporated

william.reindel@bausch.com

(585) 338-8129

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 3, 2009
• Study Start: November 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: August 15, 2011
• Results First Posted: August 11, 2011

Record last verified: 2011-07

Locations

US (1)