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Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

Primary Purpose

Vision Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PureVision Multi-Focal contact lenses
SofLens59 contact lens
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vision Disorders

Eligibility Criteria

30 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
  • Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.

Exclusion Criteria:

  • Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
  • Subjects with any systemic disease affecting ocular health
  • Subjects with an active ocular disease or using any ocular medication.
  • Subjects who have had any corneal surgery (eg, refractive surgery).

Sites / Locations

  • Bausch & Lomb

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PureVision Multi-Focal contact lenses

SofLens59 contact lens

Arm Description

Outcomes

Primary Outcome Measures

Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.
Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.

Secondary Outcome Measures

Subjective Ratings of Eye Strain
Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always

Full Information

First Posted
September 25, 2009
Last Updated
March 4, 2015
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00985231
Brief Title
Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers
Official Title
Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (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
This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PureVision Multi-Focal contact lenses
Arm Type
Experimental
Arm Title
SofLens59 contact lens
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
PureVision Multi-Focal contact lenses
Intervention Description
Contact lenses to be worn on a daily wear basis for 2 weeks.
Intervention Type
Device
Intervention Name(s)
SofLens59 contact lens
Intervention Description
Contact lenses to be worn on a daily wear basis for 2 weeks.
Primary Outcome Measure Information:
Title
Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.
Description
Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Subjective Ratings of Eye Strain
Description
Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always
Time Frame
2 week visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have clear central corneas and be free of any anterior segment disorders. Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks. Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand. Exclusion Criteria: Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation. Subjects with any systemic disease affecting ocular health Subjects with an active ocular disease or using any ocular medication. Subjects who have had any corneal surgery (eg, refractive surgery).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly J Barna
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

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