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

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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

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 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

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

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



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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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
United States, New York
Bausch & Lomb Research Clinic
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Robert Steffen, OD, MS Bausch & Lomb Incorporated

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00902850     History of Changes
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