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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01854905
First Posted: May 16, 2013
Last Update Posted: March 14, 2014
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.
Information provided by (Responsible Party):
Allergan
  Purpose
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 Intervention
Dry Eye Syndromes Other: No Treatment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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


Enrollment: 400
Study Start Date: May 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

  Contacts and Locations
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
Russian Federation
Moscow, Russian Federation
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01854905     History of Changes
Other Study ID Numbers: MAF-AGN-OPH-DE-015
First Submitted: May 14, 2013
First Posted: May 16, 2013
Results First Submitted: January 28, 2014
Results First Posted: March 14, 2014
Last Update Posted: March 14, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases