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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01854905
First received: May 14, 2013
Last updated: January 28, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854905

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01854905     History of Changes
Other Study ID Numbers: MAF-AGN-OPH-DE-015
Study First Received: May 14, 2013
Results First Received: January 28, 2014
Last Updated: January 28, 2014
Health Authority: Russia: Ethics Committee

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

ClinicalTrials.gov processed this record on September 16, 2014