TearLab Refractive Surgery Dry Eye Study

Completed

Conditions studied: Dry Eye Syndromes

In brief

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 patients who are pre-treated with ocular lubricants vs. those treated only post-operatively.

Key facts

Study ID

NCT01176045

Run by

TearLab Corporation

People needed

128

Starts

2010-06-01

Expected to finish

2011-12-01

Last updated by the study team

2016-02-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Connecticut TLC — Fairfield, Connecticut, United States
• Westchester TLC — Westchester, Illinois, United States
• Oklahoma City TLC — Oklahoma City, Oklahoma, United States
• Tulsa TLC — Tulsa, Oklahoma, United States
• Kremer Eye Center — King of Prussia, Pennsylvania, United States
• San Antonio TLC — San Antonio, Texas, United States
• Salt Lake City TLC — Salt Lake City, Utah, United States
• Reston TLC — Reston, Virginia, United States

Full record on ClinicalTrials.gov

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