Status:
COMPLETED
TearLab Refractive Surgery Dry Eye Study
Lead Sponsor:
TearLab Corporation
Collaborating Sponsors:
TLC Laser Eye Center
Abbott Medical Optics
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
21+ years
Brief Summary
The primary objective of this study is to determine how pre \& post-operative tear osmolarity levels relate to rates of dry eye symptoms related to refractive surgery and if differences exist in patie...
Detailed Description
Dry eye disease is a common and major source of disability, whether occurring as a primary disorder or as a component of other diseases and its onset may be triggered or modified by exposure to system...
Eligibility Criteria
Inclusion
- Male or female, twenty-one years of age or older.
- Confirmed diagnosis of refractive error receiving LASIK surgery.
- Patient motivation and willingness to cooperate with the investigator and ability to return for all visits during the study.
Exclusion
- Compromised cognitive ability that may be expected to interfere with study compliance.
- Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia.
- Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
- Active ocular allergy
- Patients requiring punctual occlusion prior to surgery
- Patients requiring cyclosporine ophthalmic emulsion prior to surgery
- Standard exclusion criteria for refractive surgery used by each surgeon.
- Known hypersensitivity to any of the agents used in testing
- Ophthalmologic drop use within 2 hours of any visit
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01176045
Start Date
June 1 2010
End Date
December 1 2011
Last Update
February 4 2016
Active Locations (8)
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1
Connecticut TLC
Fairfield, Connecticut, United States, 06824
2
Westchester TLC
Westchester, Illinois, United States, 60154
3
Oklahoma City TLC
Oklahoma City, Oklahoma, United States, 73116
4
Tulsa TLC
Tulsa, Oklahoma, United States, 74133