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

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ClinicalTrials.gov Identifier: NCT00768885
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : March 18, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses.

Condition or disease Intervention/treatment
Myopia Device: PureVision 1 Device: PureVision 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs
Study Start Date : September 2008
Primary Completion Date : October 2008
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768885


Locations
Japan
Kodama Eye Clinic
Kyoto, Japan, 6100121
Sponsors and Collaborators
Bausch & Lomb Incorporated
More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00768885     History of Changes
Other Study ID Numbers: MDPTLD0809
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013