Back to resultsA Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LD118033 contact lens
PureVision multifocal contact lens
Sponsored by
About this trial
This is an interventional screening trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
- Have physiologically normal anterior segments.
- Be adapted wearers of soft contact lenses and wear a lens in each eye.
- Be presbyopic and require near add correction in each eye.
- Have no active ocular disease or allergic conjunctivitis.
- Must not be using any topical ocular medications.
Exclusion Criteria:
- Any Grade 2 or greater finding during the slit lamp examination.
- Any scar or neovascularization within the central 4mm of the cornea.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Allergic to any component in the study products.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- An active ocular disease, any corneal infiltrative response or are using any ocular medications.
Sites / Locations
- Bausch & Lomb Incorporated
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LD118033 contact lens
PureVision multifocal contact lens
Arm Description
Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.
PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.
Outcomes
Primary Outcome Measures
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Secondary Outcome Measures
Symptoms/Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Full Information
NCT ID
NCT01539694
First Posted
February 15, 2012
Last Updated
September 9, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01539694
Brief Title
A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
Official Title
A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (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 product performance of an investigational multifocal low add soft contact lens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LD118033 contact lens
Arm Type
Experimental
Arm Description
Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.
Arm Title
PureVision multifocal contact lens
Arm Type
Active Comparator
Arm Description
PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.
Intervention Type
Device
Intervention Name(s)
LD118033 contact lens
Intervention Description
Multifocal contact lens worn on a daily wear basis for 1 week
Intervention Type
Device
Intervention Name(s)
PureVision multifocal contact lens
Intervention Description
PureVision multifocal contact lens worn on a daily wear basis for 1 week.
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Time Frame
At 1 week follow up
Secondary Outcome Measure Information:
Title
Symptoms/Complaints
Description
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Time Frame
At 1 week follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have physiologically normal anterior segments.
Be adapted wearers of soft contact lenses and wear a lens in each eye.
Be presbyopic and require near add correction in each eye.
Have no active ocular disease or allergic conjunctivitis.
Must not be using any topical ocular medications.
Exclusion Criteria:
Any Grade 2 or greater finding during the slit lamp examination.
Any scar or neovascularization within the central 4mm of the cornea.
Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Allergic to any component in the study products.
Any systemic disease affecting ocular health.
Using any systemic or topical medications that will affect ocular physiology or lens performance.
An active ocular disease, any corneal infiltrative response or are using any ocular medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Cairns, PhD, MCOptom
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
Learn more about this trial
A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
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