NCT00818909

Brief Summary

To evaluate the physical effect of SYSTANE QID in people that have moderate to severe dry eyes and to establish doctor confidence to prescribe Systane.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
941

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

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

January 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

January 7, 2009

Last Update Submit

January 31, 2012

Conditions

Dry Eye Syndrome

Keywords

Dry eyeSystaneModerate to severe dry eye

Outcome Measures

Primary Outcomes (1)

  • corneal and conjunctiva staining score

    4 weeks

Secondary Outcomes (1)

  • Tear film break up time

    4 weeks

Study Arms (1)

Systane

EXPERIMENTAL

Systane ocular product

Other: Systane

Interventions

SystaneOTHER

Systane prescription

Systane

Eligibility Criteria

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

You may qualify if:

  • moderate to severe dry feeling eyes

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 2, 2012

Record last verified: 2012-01