An Observational Study of Dry Eye Prior to Laser-Assisted in Situ Keratomileusis (LASIK) Therapy

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Other: No Treatment

• Registration Number: NCT01854905
• Lead Sponsor: Allergan

Brief Summary

This is an observational, study of dry eye in patients at the consultation visit prior to LASIK surgery. There is no treatment administered or intervention during the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-16
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-01
• Results First Submitted: 2014-01-28
• Results First Submitted QC: 2014-01-28
• Last Update Submitted: 2014-01-28
• Results First Posted: 2014-03-14
• Last Update Posted: 2014-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Attending an ophthalmology consultation for LASIK

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Attending Consultation for LASIK	No Treatment	Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale	Day 1	The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress