A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01024751 |
Recruitment Status :
Completed
First Posted : December 3, 2009
Results First Posted : August 11, 2011
Last Update Posted : August 15, 2011
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ocular Discomfort | Device: Bausch & Lomb Multi-Purpose Solution Device: Ciba's Multi-Purpose Solution | Not Applicable |
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 |
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. |
- 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.
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024751
United States, New York | |
Bausch & Lomb | |
Rochester, New York, United States, 14609 |
Responsible Party: | Mohinder Merchea, OD, PhD, MBA, Bausch & Lomb Incorporated |
ClinicalTrials.gov Identifier: | NCT01024751 |
Other Study ID Numbers: |
636 |
First Posted: | December 3, 2009 Key Record Dates |
Results First Posted: | August 11, 2011 |
Last Update Posted: | August 15, 2011 |
Last Verified: | July 2011 |
Pharmaceutical Solutions |