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

This study has been completed.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated Identifier:
First received: May 14, 2009
Last updated: February 13, 2015
Last verified: February 2015
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 Intervention
Device: SofLens Daily Disposable
Device: Marketed 1 Day Contact Lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to 1-Day Acuvue TruEye Lenses

Resource links provided by NLM:

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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.

Enrollment: 28
Study Start Date: October 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00902850

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

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00902850     History of Changes
Other Study ID Numbers: ROC2-08-169
Study First Received: May 14, 2009
Results First Received: February 13, 2015
Last Updated: February 13, 2015 processed this record on May 25, 2017