NCT00347984

Brief Summary

The objective of this study was to evaluate the effect of Systane® compared to marketed artificial tears on the frequency of drop use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2005

Shorter than P25 for not_applicable

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

December 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

April 10, 2012

Status Verified

August 1, 2008

Enrollment Period

2 months

First QC Date

June 30, 2006

Last Update Submit

April 7, 2012

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Frequency of drop use and/or desire to use; Drop preference

Secondary Outcomes (1)

  • Product questionnaire; Symptoms; Corneal and conjunctival staining; Tear film break-up time (TFBUT).

Interventions

Systane Lubricant eye dropsOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects age 18 (minimum); reported history of dry eye syndrome in both eyes; TFBUT ≤ 7 seconds in at least 1 eye at Visit 1; ≥ 1+ fluorescein staining score in any region in at least 1 eye at Visit 1; desire to use an artificial tear substitute for dry eye symptoms at least 4 times per day at Visit 1 and Visit 2.

You may not qualify if:

  • Age less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maryland

Andover, Massachusetts, 01845, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Mike Christensen

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

December 1, 2005

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

April 10, 2012

Record last verified: 2008-08

Locations

US(1)