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Study of A New Contact Lens Cleaning and Disinfecting Solution

Primary Purpose

Vision Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigational Cleaning & Disinfecting Solution
Clear Care Solution
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vision Disorders focused on measuring Contact lens, Cleaning solution

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bausch & Lomb Incorporated

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational Solution

Clear Care Solution

Arm Description

Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses.

Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses

Outcomes

Primary Outcome Measures

Percentage of Eyes With > Grade 2 Slit Lamp Findings
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.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2011
Last Updated
October 5, 2020
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01318577
Brief Title
Study of A New Contact Lens Cleaning and Disinfecting Solution
Official Title
Study of A New Contact Lens Cleaning and Disinfecting Solution
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision Disorders
Keywords
Contact lens, Cleaning solution

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Solution
Arm Type
Experimental
Arm Description
Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses.
Arm Title
Clear Care Solution
Arm Type
Active Comparator
Arm Description
Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses
Intervention Type
Device
Intervention Name(s)
Investigational Cleaning & Disinfecting Solution
Intervention Description
Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
Intervention Type
Device
Intervention Name(s)
Clear Care Solution
Intervention Description
Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
Primary Outcome Measure Information:
Title
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly Barna
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Incorporated
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

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Study of A New Contact Lens Cleaning and Disinfecting Solution

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