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Tear Evaluation Between Habitual Contact Lens Wearers and Non Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01317030
First received: March 9, 2011
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  Purpose

The objective of this study is to evaluate tears between habitual contact lens wearers and non contact lens wearers using a Schirmer Strip for tear collection.


Condition Intervention
Dry Eye
 Device: Contact Lens Wear
Other: Non-Contact Lens Wear

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Tear Evaluation Between Habitual Contact Lens Wearers and Non Contact Lens Wearers Using a Schirmer Strip for Tear Collection

Resource links provided by NLM:

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

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Hyaluronan Levels [ Time Frame: Overall study visits up to 7 days following lens insertion ] [ Designated as safety issue: No ]
    Tear samples collected using a Schirmer tear strip and analyzed for hyaluronan (HA)levels, a lubricant found throughout the body, including tears. Levels will be compared between the lens wearers and non-lens wearers.


Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: Overall study visits for up to 2 weeks ] [ Designated as safety issue: No ]
    Monocular Snellen Visual Acuity (VA)


Enrollment: 30
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contact Lens Wear
Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution
 Device: Contact Lens Wear
Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye.
Device: Contact Lens Wear
Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye.
Placebo Comparator: Non-Contact Lens Wear Other: Non-Contact Lens Wear
No intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have no allergic conjunctivitis.
  • Not be using any topical ocular medications.

Exclusion Criteria:

  • Considered by the Investigator to not be a suitable candidate for participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317030

Locations
United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Stephanie Su, OD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01317030     History of Changes
Other Study ID Numbers: ROC2-10-110
Study First Received: March 9, 2011
Last Updated: March 15, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013