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NCT01854905 Clinical Trial

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

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01854905
Other study ID # MAF-AGN-OPH-DE-015
Secondary ID
Status Completed
Phase N/A
First received May 14, 2013
Last updated January 28, 2014
Start date May 2013
Est. completion date September 2013

Study information
Verified date January 2014
Source Allergan
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Attending an ophthalmology consultation for LASIK

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• No Treatment
Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale 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 Day 1 No
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