TearLab Refractive Surgery Dry Eye Study

Completed

• Conditions: Dry Eye Syndromes

• Registration Number: NCT01176045
• Lead Sponsor: TearLab Corporation

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

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 systemic drugs, contact lens wear, ocular surgery and adverse environmental and work conditions. The development of a reliable, highly sensitive and specific test for the clinical diagnosis of dry eye is a major unmet clinical need, particularly to differentiate it from common conditions such as ocular allergy which exhibit similar presenting symptoms. Tear hyper-osmolarity is central to the dry eye disease process and the measurement of tear osmolarity could serve not only as a highly accurate diagnostic test but also as a measure of disease severity and a means to monitor treatment efficacy.

Recently, there have been reports in the literature regarding dry eye disease; both early and chronic following refractive surgery, with many cases potentially being previously inadvertently undiagnosed dry eye disease.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relation of pre & post-operative tear osmolarity levels to dry eye and dry eye symptoms in refractive surgery	6 months post surgery

Secondary Outcome Measures

Name	Time	Method
To determine if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively	6 months post-surgical
To determine if tear osmolarity levels relate to visual acuity outcomes related to refractive surgery	6 months post-surgical

Trial Locations

Locations (8)

Westchester TLC; 🇺🇸 Westchester, Illinois, United States

Tulsa TLC; 🇺🇸 Tulsa, Oklahoma, United States

Connecticut TLC; 🇺🇸 Fairfield, Connecticut, United States

Oklahoma City TLC; 🇺🇸 Oklahoma City, Oklahoma, 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

Kremer Eye Center; 🇺🇸 King of Prussia, Pennsylvania, United States