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Study of A New Contact Lens Cleaning and Disinfecting 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: NCT01318577
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vision Disorders Device: Investigational Cleaning & Disinfecting Solution Device: Clear Care Solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Study of A New Contact Lens Cleaning and Disinfecting Solution
Study Start Date : November 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Investigational Solution
Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses.
Device: Investigational Cleaning & Disinfecting Solution
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
Device: Clear Care Solution
Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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): NCT01318577


Locations
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United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Beverly Barna Bausch & Lomb Incorporated
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01318577    
Other Study ID Numbers: 682
First Posted: March 18, 2011    Key Record Dates
Results First Posted: October 8, 2020
Last Update Posted: October 8, 2020
Last Verified: October 2020
Keywords provided by Bausch & Lomb Incorporated:
Contact lens
Cleaning solution
Additional relevant MeSH terms:
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Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Pharmaceutical Solutions