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NCT01317030 Clinical Trial

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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01317030
Other study ID # ROC2-10-110
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 2011
Est. completion date April 2011

Study information
Verified date January 2020
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 25
Est. completion date April 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• 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.
Other:
• Non-Contact Lens Wear
No intervention

Locations
Country Name City State
United States Bausch & Lomb Incorporated Rochester New York

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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