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

Tear Evaluation Between Habitual Contact Lens Wearers and Non Contact Lens Wearers Using a Schirmer Strip for Tear Collection

to evaluate tears between habitual contact lens wearers and non contact lens wearers

Study Overview

• Status: Terminated
• Conditions: Dry Eye
• Intervention / Treatment: Device: Contact Lens Wear; Device: Contact Lens Wear; Other: Non-Contact Lens Wear

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch & Lomb Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Specific characteristics are that one group will be habitual contact lens wearers, and the other group will be non-contact lens wearers (not having worn contact lenses within the last 7 days prior to baseline visit)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
Non-Contact Lens Wear	Other: Non-Contact Lens Wear; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyaluronan Levels	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.	7 days following lens insertion

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Robert Steffen, OD, MS, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: March 9, 2011
• First Submitted That Met QC Criteria: March 15, 2011
• First Posted (Estimate): March 17, 2011

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: ROC2-10-110