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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00768885
First received: October 6, 2008
Last updated: March 15, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention
Myopia
Device: PureVision 1
Device: PureVision 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Patient satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: September 2008
Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768885

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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00768885     History of Changes
Other Study ID Numbers: MDPTLD0809
Study First Received: October 6, 2008
Last Updated: March 15, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014