NCT01066988

Brief Summary

The purpose of this study is to evaluate the effects of an investigational lubricant eye drop on tear film lipid layer thickness of dry eye patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 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

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
Last Updated

November 18, 2016

Status Verified

February 1, 2012

Enrollment Period

1 month

First QC Date

February 9, 2010

Last Update Submit

November 17, 2016

Conditions

Dry Eye

Keywords

lipid layer thickness

Outcome Measures

Primary Outcomes (1)

  • Lipid layer thickness

    Baseline through 120 minutes post instillation

Study Arms (2)

Right Eye

OTHER

ORB Ocular Emulsion or SootheXP

Other: ORB Ocular Emulsion

Left Eye

OTHER

ORB Ocular Emulsion or SootheXP

Other: SootheXP Emollient (Lubricant) Eye Drops

Interventions

ORB Ocular EmulsionOTHER

lubricant eye drop

Right Eye
SootheXP Emollient (Lubricant) Eye DropsOTHER

lubricant eye drop

Left Eye

Eligibility Criteria

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

You may qualify if:

  • Patients (minimum age 18) meeting specific criteria for dry eye.

You may not qualify if:

  • Use of topical ocular drops within 12 hours of the study visit; or use of topical ocular ointment within 36 hours of the study visit. In addition, cannot use any topical ocular drugs during study period.
  • History or evidence of ocular or systemic medical conditions and/or medications that would confound the evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

Related Publications (1)

  • Benelli U. Systane lubricant eye drops in the management of ocular dryness. Clin Ophthalmol. 2011;5:783-90. doi: 10.2147/OPTH.S13773. Epub 2011 Jun 10.

    PMID: 21750611RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

LubricantsOphthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and UsesPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic Actions

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

February 9, 2010

First Posted

February 11, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2010

Last Updated

November 18, 2016

Record last verified: 2012-02

Locations

US(1)