NCT00345241

Brief Summary

To evaluate tear film stability of a market lubricant therapeutic eye drop versus saline when using Evaporometry and Interferometry in patients with a diagnosis of Keratoconjunctivitis Sicca (KCS). The purpose of this research is to evaluate evaporative parameters and tear film quality when using Systane lubricating eye drops versus saline in the eyes of dry eye patients at pre-instillation and at 30 and 60 minutes post instillation of drop(s).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

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

Study Start

First participant enrolled

January 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 23, 2008

Status Verified

June 1, 2008

Enrollment Period

11 months

First QC Date

June 23, 2006

Last Update Submit

June 19, 2008

Conditions

Keratoconjunctivitis Sicca

Keywords

Blepharitis

Outcome Measures

Primary Outcomes (1)

  • Evaporametry changes pre and post instillation of test articles in patients with KCS

    In Clinic Visit

Interventions

Systane Ocular Drops (OTC)DRUG
Placebo - Saline DropsDRUG

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390-8866, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis SiccaBlepharitis

Condition Hierarchy (Ancestors)

KeratoconjunctivitisConjunctivitisConjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEyelid Diseases

Study Officials

  • Harrison D. Cavanagh, M.D.

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 27, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

June 23, 2008

Record last verified: 2008-06

Locations

US(1)