TearLab Refractive Surgery Dry Eye Study

Dry Eye Syndromes Clinical Trial

Official title:

Measurement of Refractive Surgery Induced Dry Eye Using Tear Osmolarity Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176045
• Other study ID #: TP00087
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2010
• Last updated: February 2, 2016
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2016
• Source: TearLab Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
TearLab Corporation	Abbott Medical Optics, TLC Laser Eye Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relation of pre & post-operative tear osmolarity levels to dry eye and dry eye symptoms in refractive surgery		6 months post surgery	No
Secondary	To determine if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively		6 months post-surgical	No
Secondary	To determine if tear osmolarity levels relate to visual acuity outcomes related to refractive surgery		6 months post-surgical	No