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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01854905
Recruitment Status : Completed
First Posted : May 16, 2013
Results First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease Intervention/treatment
Dry Eye Syndromes Other: No Treatment

Study Design
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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : May 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients Attending Consultation for LASIK
Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
 Other: No Treatment
Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients consulting with ophthalmologist for possible LASIK
Criteria

Inclusion Criteria:

  • Attending an ophthalmology consultation for LASIK

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854905


Locations
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Russian Federation
Moscow, Russian Federation
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01854905    
Other Study ID Numbers: MAF-AGN-OPH-DE-015
First Posted: May 16, 2013    Key Record Dates
Results First Posted: March 14, 2014
Last Update Posted: March 14, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases