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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00985231
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : March 14, 2011
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Vision Disorders Device: PureVision Multi-Focal contact lenses Device: SofLens59 contact lens

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers
Study Start Date : September 2009
Primary Completion Date : November 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40. [ Time Frame: 2 weeks ]
    Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.


Secondary Outcome Measures :
  1. Subjective Ratings of Eye Strain [ Time Frame: 2 week visit ]
    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00985231     History of Changes
Other Study ID Numbers: 630
First Posted: September 28, 2009    Key Record Dates
Results First Posted: March 14, 2011
Last Update Posted: March 24, 2015
Last Verified: March 2015

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