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Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00985231
First received: September 25, 2009
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.


Condition Intervention
Vision Disorders
 Device: PureVision Multi-Focal contact lenses
Device: SofLens59 contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

Resource links provided by NLM:

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

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.


Secondary Outcome Measures:
  • Subjective Ratings of Eye Strain [ Time Frame: 2 week visit ] [ Designated as safety issue: No ]
    Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always


Enrollment: 272
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PureVision Multi-Focal contact lenses Device: PureVision Multi-Focal contact lenses
Contact lenses to be worn on a daily wear basis for 2 weeks.
Active Comparator: SofLens59 contact lens Device: SofLens59 contact lens
Contact lenses to be worn on a daily wear basis for 2 weeks.

  Eligibility

Ages Eligible for Study:   30 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
  • Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.

Exclusion Criteria:

  • Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
  • Subjects with any systemic disease affecting ocular health
  • Subjects with an active ocular disease or using any ocular medication.
  • Subjects who have had any corneal surgery (eg, refractive surgery).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985231

Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Beverly J Barna Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00985231     History of Changes
Other Study ID Numbers: 630
Study First Received: September 25, 2009
Results First Received: February 17, 2011
Last Updated: December 8, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vision Disorders
Sensation Disorders
Neurologic Manifestations
 Nervous System Diseases
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013