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

March 15, 2013 updated by: Bausch & Lomb Incorporated

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

To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 6100121
        • Kodama Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PureVision 1
PureVision soft contact lens design #1.
Device: PureVision 1
Currently marketed PureVision soft contact lens.
Experimental: PureVision 2
PureVision soft contact lens design #2
Device: PureVision 2
Alternate design soft contact lens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 6, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimate)

October 8, 2008

Study Record Updates

Last Update Posted (Estimate)

March 18, 2013

Last Update Submitted That Met QC Criteria

March 15, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDPTLD0809

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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