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
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 April 22, 2014