NCT00348322

Brief Summary

The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 in comparison to Refresh Tears Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2006

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

First Submitted

Initial submission to the registry

June 30, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2008

Enrollment Period

4 months

First QC Date

June 30, 2006

Last Update Submit

September 23, 2008

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Corneal Staining change from baseline

Secondary Outcomes (1)

  • Comfort, Conjunctival Staining

Interventions

Systane Free Lubricant Eye DropsDRUG

Eligibility Criteria

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

You may qualify if:

  • \> = 3 stain using NEI grid and need artificial tears at least some of the time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Paso Facility

El Paso, Texas, 79904, 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
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

July 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

US(1)