A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigational contact lens
PureVision contact lens
Sponsored by
About this trial
This is an interventional treatment 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.
- Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
- Have no active ocular disease or allergic conjunctivitis.
- Must not be using any topical ocular medications.
- Must habitually use a lens care product for lens cleaning, disinfecting, and storage.
Exclusion Criteria:
- Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Anisometropia (spherical equivalent) of greater than 2.00 D.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- Allergic to any component in the study products.
- Ocular astigmatism of greater than 1.00 D in either eye.
- Have had any corneal surgery (ie, refractive surgery).
- Uses AMO Ultra Care as their habitual lens care regimen.
- Is a toric contact lens wearer.
- Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
- An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), 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
Investigational contact lens
PureVision contact lens
Arm Description
multifocal high add soft contact lens
Multi-focal contact lens
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
NCT01518868
First Posted
January 24, 2012
Last Updated
September 9, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01518868
Brief Title
A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
Official Title
A Study to Evaluate the Feasibility of a High Add Multi Focal 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
February 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 the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational contact lens
Arm Type
Experimental
Arm Description
multifocal high add soft contact lens
Arm Title
PureVision contact lens
Arm Type
Active Comparator
Arm Description
Multi-focal contact lens
Intervention Type
Device
Intervention Name(s)
Investigational contact lens
Intervention Description
Worn on a daily wear basis for one week.
Intervention Type
Device
Intervention Name(s)
PureVision contact lens
Intervention Description
Worn on a daily wear basis for one 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 2 weeks 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 2 weeks 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.
Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
Have no active ocular disease or allergic conjunctivitis.
Must not be using any topical ocular medications.
Must habitually use a lens care product for lens cleaning, disinfecting, and storage.
Exclusion Criteria:
Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Anisometropia (spherical equivalent) of greater than 2.00 D.
Any systemic disease affecting ocular health.
Using any systemic or topical medications that will affect ocular physiology or lens performance.
Allergic to any component in the study products.
Ocular astigmatism of greater than 1.00 D in either eye.
Have had any corneal surgery (ie, refractive surgery).
Uses AMO Ultra Care as their habitual lens care regimen.
Is a toric contact lens wearer.
Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly J Barna, CCRA
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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A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
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