- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01318577
Study of A New Contact Lens Cleaning and Disinfecting Solution
October 5, 2020 updated by: Bausch & Lomb Incorporated
The objective of this study is to evaluate the safety and efficacy of a new investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
444
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14609
- Bausch & Lomb Incorporated
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must be habitual wearers of one of the protocol specified lenses.
- Subjects must habitually use a NON-PEROXIDE lens care product for cleaning, disinfecting and storage of their lenses.
- Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
- Subjects must agree to wear their lenses on a daily wear basis for approximately three months.
Exclusion Criteria:
- Subjects who currently use a hydrogen peroxide cleaning and disinfecting solution.
- Subjects who currently wear Opaque Cosmetic Tint Contact Lenses.
- Subjects who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Subjects with any systemic disease currently affecting ocular health or which in the Investigator"s opinion may have an effect on ocular health during the course of the study.
- Subjects using any systemic or topical medications that will, in the Investigator"s opinion, affect ocular physiology or lens performance.
- Subjects with any "Present" finding during the slit lamp examination that, in the Investigator"s judgment, interferes with contact lens wear.
- Subjects with any scar or neovascularization within the central 4 mm of the cornea.
- Subjects who are allergic to any component in the study care products.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigational Solution
Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses.
|
Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
|
Active Comparator: Clear Care Solution
Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses
|
Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Time Frame: 3 months
|
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding).
The outcome measure is any finding > grade 2, across abnormalities.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Beverly Barna, Bausch & Lomb Incorporated
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
March 16, 2011
First Submitted That Met QC Criteria
March 17, 2011
First Posted (Estimate)
March 18, 2011
Study Record Updates
Last Update Posted (Actual)
October 8, 2020
Last Update Submitted That Met QC Criteria
October 5, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 682
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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