NCT00348517

Brief Summary

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

Trial Health

100
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

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

March 5, 2012

Status Verified

March 1, 2012

Enrollment Period

4 months

First QC Date

June 30, 2006

Last Update Submit

March 2, 2012

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Change in corneal staining at Day 28 from baseline (Day 0)

    Day 28

Study Arms (2)

Systane

EXPERIMENTAL
Other: Systane Free Lubricant Eye Drops

Refresh

ACTIVE COMPARATOR
Other: Refresh Liquigel Lubricant Eye Drops

Interventions

Systane Free Lubricant Eye DropsOTHER

1-2 drops per eye four times per day for 42 days

Systane
Refresh Liquigel Lubricant Eye DropsOTHER

1-2 drops per eye four times per day for 42 days

Refresh

Eligibility Criteria

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

You may qualify if:

  • \>/= 3 corneal staining score using NEI scoring system.
  • Need artificial tears at least some of the time.

You may not qualify if:

  • History or evidence of ocular or intraocular surgery in either eye within the past six months.
  • History of intolerance or hypersensitivity to any component of the study medication.
  • Use of Restasis within 30 days of Visit 1.
  • Participation in an investigational drug or device study within 30 days of entering this study.

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
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

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

March 5, 2012

Record last verified: 2012-03