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
  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:


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
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: 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 September 18, 2014