NCT01854905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 14, 2014

Completed
Last Updated

March 14, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

May 14, 2013

Results QC Date

January 28, 2014

Last Update Submit

January 28, 2014

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

No TreatmentOTHER

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

Patients Attending Consultation for LASIK

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting with ophthalmologist for possible LASIK

You may qualify if:

  • Attending an ophthalmology consultation for LASIK

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Moscow, Russia

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 16, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 14, 2014

Results First Posted

March 14, 2014

Record last verified: 2014-01

Locations

RU(1)