TearLab Refractive Surgery Dry Eye Study

NCT01176045 | Completed

• 1 other identifier: TP00087
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 8

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.

Conditions

Dry Eye Syndromes

Keywords

Dry Eye Disease; Osmolarity; Refractive Surgery; Lasik; TearLab

Outcome Measures

Primary Outcomes (1)

• Relation of pre & post-operative tear osmolarity levels to dry eye and dry eye symptoms in refractive surgery

  6 months post surgery

Secondary Outcomes (2)

• 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

Study Arms (2)

Pre-surgical treatment

Patients who are pre \& post-surgical treated with ocular lubricants.

Non-presurgical treatment

Patients who are only post-surgical treated with ocular lubricants

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo refractive surgery with no previous diagnosis of dry eye disease.

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
• Known hypersensitivity to any of the agents used in testing
• Ophthalmologic drop use within 2 hours of any visit

Sponsors & Collaborators

• TearLab Corporation: lead
• TLC Laser Eye Center: collaborator
• Abbott Medical Optics: collaborator

Study Sites (8)

Connecticut TLC

Fairfield, Connecticut, 06824, United States

Location

Westchester TLC

Westchester, Illinois, 60154, United States

Location

Oklahoma City TLC

Oklahoma City, Oklahoma, 73116, United States

Location

Tulsa TLC

Tulsa, Oklahoma, 74133, United States

Location

Kremer Eye Center

King of Prussia, Pennsylvania, 16406, United States

Location

San Antonio TLC

San Antonio, Texas, 78232, United States

Location

Salt Lake City TLC

Salt Lake City, Utah, 84121, United States

Location

Reston TLC

Reston, Virginia, 20191, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• James Owen, OD

  TLC The Laser Eye Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 5, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

US (8)