search
Back to results

Comparative Performance of PureVision Lens Designs

Primary Purpose

Myopia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Currently Marketed PureVision Contact Lens.
Alternate Design of the PureVision Contact Lens.
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • subject is myopic
  • VA correctable to 0.3 logMAR or better (driving vision)
  • Clear central cornea

Exclusion Criteria:

  • Systemic disease affecting ocular health
  • using systemic or topical medications
  • wear monovision, multifocal or toric contact lenses
  • Any grade 2 or greater slit lamp findings

Sites / Locations

  • Laser Focus Sdn Bhd, Vision Correction Centre
  • Asian Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Purevision Contact Lens #1

PureVision Contact Lens #2

Arm Description

PureVision Soft Contact Lens Design (currently marketed)

Redesign of the currently marketed PureVision soft contact lens.

Outcomes

Primary Outcome Measures

Subjective Responses to Symptoms/Complaints
Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.

Secondary Outcome Measures

LogMAR Visual Acuity
The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.
Lens Characteristics
Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.

Full Information

First Posted
April 16, 2008
Last Updated
December 7, 2011
Sponsor
Bausch & Lomb Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT00661687
Brief Title
Comparative Performance of PureVision Lens Designs
Official Title
A Study to Evaluate the Product Performance of the Redesigned Bausch & Lomb PureVision® Contact Lens (Test) Compared to the Currently Marketed Bausch & Lomb PureVision® Contact Lens (Control) When Worn on an Extended Wear Basis.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
June 2008 (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 performance of the PureVision Lens designs when worn on a 30-day continuous wear basis

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Purevision Contact Lens #1
Arm Type
Active Comparator
Arm Description
PureVision Soft Contact Lens Design (currently marketed)
Arm Title
PureVision Contact Lens #2
Arm Type
Experimental
Arm Description
Redesign of the currently marketed PureVision soft contact lens.
Intervention Type
Device
Intervention Name(s)
Currently Marketed PureVision Contact Lens.
Intervention Description
Contact lens for continuous wear
Intervention Type
Device
Intervention Name(s)
Alternate Design of the PureVision Contact Lens.
Intervention Description
Contact lens for continuous wear
Primary Outcome Measure Information:
Title
Subjective Responses to Symptoms/Complaints
Description
Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.
Time Frame
Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits
Secondary Outcome Measure Information:
Title
LogMAR Visual Acuity
Description
The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.
Time Frame
Mean over all visits - 1 day, 1 week, 1 month
Title
Lens Characteristics
Description
Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.
Time Frame
Over all scheduled visits day 1 - 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subject is myopic VA correctable to 0.3 logMAR or better (driving vision) Clear central cornea Exclusion Criteria: Systemic disease affecting ocular health using systemic or topical medications wear monovision, multifocal or toric contact lenses Any grade 2 or greater slit lamp findings
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Cairns, MCOptom, PhD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Benny Chian, MCOptom
Organizational Affiliation
Laser Focus Sdn Bhd, Vision Correction Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harvey Siy Uy, MD
Organizational Affiliation
Asian Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laser Focus Sdn Bhd, Vision Correction Centre
City
Johor Bahru
ZIP/Postal Code
80400
Country
Malaysia
Facility Name
Asian Eye Institute
City
Makati City
ZIP/Postal Code
1200
Country
Philippines

12. IPD Sharing Statement

Learn more about this trial

Comparative Performance of PureVision Lens Designs

We'll reach out to this number within 24 hrs