NCT01311609

Brief Summary

This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2010

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

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

8 months

First QC Date

March 8, 2011

Last Update Submit

January 31, 2012

Conditions

Moderate to Severe Dry Eye

Keywords

Systane, Dry Eye

Outcome Measures

Primary Outcomes (2)

  • Corneal Staining

    Visit 2 (Week 2) - change from baseline

  • Best-corrected visual acuity

    Visit 2 (Week 2) - change from baseline

Study Arms (1)

Systane

EXPERIMENTAL

Systane Lubricant Eye Drops

Other: Systane

Interventions

SystaneOTHER

Systane Lubricant Eye Drops \[1-2 Drops in each eye four times daily (QID)\]

Systane

Eligibility Criteria

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

You may qualify if:

  • years of age or older, of both sexes, and any race.
  • Willing and able to make all required visits and follow study instructions.
  • A sodium fluorescein corneal staining sum of \>/ 3 in either eye. A best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed during an ETDRS chart

You may not qualify if:

  • A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
  • Lasik patients can be included if Lasik surgery was \> 6 months prior to the initiation of the study.
  • A history of intolerance or hypersensitivity to any component of the study medications.

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

March 8, 2011

First Posted

March 9, 2011

Study Start

November 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 2, 2012

Record last verified: 2012-01