Study Stopped
Study was terminated due to a business decision to cancel the entire project.
Tear Evaluation Between Habitual Contact Lens Wearers and Non Contact Lens Wearers
1 other identifier
observational
25
1 country
1
Brief Summary
to evaluate tears between habitual contact lens wearers and non contact lens wearers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 9, 2011
CompletedFirst Posted
Study publicly available on registry
March 17, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
January 9, 2020
CompletedJanuary 9, 2020
January 1, 2020
28 days
March 9, 2011
November 4, 2014
January 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Contact Lens Wear
Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution
Non-Contact Lens Wear
Interventions
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.
Eligibility Criteria
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)
You may qualify if:
- Have no allergic conjunctivitis.
- Not be using any topical ocular medications.
You may not qualify if:
- Considered by the Investigator to not be a suitable candidate for participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb Incorporated
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Steffen, O.D., M.S.
- Organization
- Bausch & Lomb Incorporated
Study Officials
- STUDY DIRECTOR
Robert Steffen, OD, MS
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2011
First Posted
March 17, 2011
Study Start
February 1, 2011
Primary Completion
March 1, 2011
Study Completion
April 1, 2011
Last Updated
January 9, 2020
Results First Posted
January 9, 2020
Record last verified: 2020-01