search
Back to results

Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs.

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
PureVision 1
PureVision 2
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Myopia

Eligibility Criteria

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

Inclusion Criteria:

  • Subject is myopic
  • Subjects who wear soft contact lenses that are exchanged at least biweekly at the time consent is obtained.

Exclusion Criteria:

  • Systemic disease affecting ocular health
  • Using pharmaceuticals that may affect the function of the eyes or lenses.
  • Subject possessing corneal infiltrate or corneal ulcers.

Sites / Locations

  • Kodama Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PureVision 1

PureVision 2

Arm Description

PureVision soft contact lens design #1.

PureVision soft contact lens design #2

Outcomes

Primary Outcome Measures

Patient satisfaction

Secondary Outcome Measures

Full Information

First Posted
October 6, 2008
Last Updated
March 15, 2013
Sponsor
Bausch & Lomb Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT00768885
Brief Title
Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs.
Official Title
Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
January 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
To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses.

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
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PureVision 1
Arm Type
Active Comparator
Arm Description
PureVision soft contact lens design #1.
Arm Title
PureVision 2
Arm Type
Experimental
Arm Description
PureVision soft contact lens design #2
Intervention Type
Device
Intervention Name(s)
PureVision 1
Intervention Description
Currently marketed PureVision soft contact lens.
Intervention Type
Device
Intervention Name(s)
PureVision 2
Intervention Description
Alternate design soft contact lens.
Primary Outcome Measure Information:
Title
Patient satisfaction
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject is myopic Subjects who wear soft contact lenses that are exchanged at least biweekly at the time consent is obtained. Exclusion Criteria: Systemic disease affecting ocular health Using pharmaceuticals that may affect the function of the eyes or lenses. Subject possessing corneal infiltrate or corneal ulcers.
Facility Information:
Facility Name
Kodama Eye Clinic
City
Kyoto
ZIP/Postal Code
6100121
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs.

We'll reach out to this number within 24 hrs