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
  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:


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
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, see Learn About Clinical Studies.

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 July 20, 2014