NCT00946777

Brief Summary

The primary objective is to determine if there is a correlation between reductions in corneal staining and improvements in corneal barrier function.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

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

Study Start

First participant enrolled

July 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 18, 2016

Status Verified

February 1, 2012

Enrollment Period

2 months

First QC Date

July 24, 2009

Last Update Submit

November 17, 2016

Conditions

Dry Eye

Keywords

Dry Eye Signsbarrier function

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline of corneal fluorescein

    30 days

Secondary Outcomes (1)

  • Adverse event occurence

    30 Days

Study Arms (1)

Systane® Ultra

EXPERIMENTAL
Other: Systane® Ultra

Interventions

Systane® UltraOTHER

Systane® Ultra 1-2 drops, 4 times per day for 30 days

Systane® Ultra

Eligibility Criteria

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

You may qualify if:

  • Patients must have moderate corneal staining and exhibit a need to use artificial tears.

You may not qualify if:

  • Patients can not participate in any other ophthalmic drug or device clinical trial within 30 days of the baseline visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fernandez KB, Epstein SP, Raynor GS, Sheyman AT, Massingale ML, Dentone PG, Landegger LD, Asbell PA. Modulation of HLA-DR in dry eye patients following 30 days of treatment with a lubricant eyedrop solution. Clin Ophthalmol. 2015 Jun 24;9:1137-45. doi: 10.2147/OPTH.S81355. eCollection 2015.

    PMID: 26170605RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

July 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 18, 2016

Record last verified: 2012-02