Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens

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: NCT00902850
Recruitment Status : Completed
First Posted : May 15, 2009
Results First Posted : March 2, 2015
Last Update Posted : March 2, 2015
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The objective of this one-day study will be to evaluate the clinical performance of SofLens Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.

Condition or disease Intervention/treatment Phase
Myopia Device: SofLens Daily Disposable Device: Marketed 1 Day Contact Lens Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to 1-Day Acuvue TruEye Lenses
Study Start Date : October 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: SofLens Daily Disposable
SofLens Daily Disposable Lenses
 Device: SofLens Daily Disposable
Lenses to be worn for 8-16 hours
Active Comparator: Marketed 1 Day Contact Lens
Marketed 1 Day Contact Lens
 Device: Marketed 1 Day Contact Lens
Lenses to be worn for 8-16 hours


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Clinical Performance [ Time Frame: Insertion, 4 hours & End of Day ]
    Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • Have no active ocular disease or allergic conjunctivitis.
  • Not be using any topical ocular medications.

Exclusion Criteria:

  • Participating in a conflicting study.
  • Considered by the Investigator to not be a suitable candidate for participation.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00902850


Locations
Layout table for location information
United States, New York
Bausch & Lomb Research Clinic
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Layout table for investigator information
Study Director: Robert Steffen, OD, MS Bausch & Lomb Incorporated
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00902850    
Other Study ID Numbers: ROC2-08-169
First Posted: May 15, 2009    Key Record Dates
Results First Posted: March 2, 2015
Last Update Posted: March 2, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Myopia
Refractive Errors
Eye Diseases