NCT00347854

Brief Summary

The objective of this study is to evaluate the safety and efficacy of exaggerated use of Lubricant Eye Drops in a population of normal subjects by measuring corneal epithelial permeability to fluorescein.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 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

April 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

November 22, 2016

Status Verified

February 1, 2012

Enrollment Period

Same day

First QC Date

June 30, 2006

Last Update Submit

November 18, 2016

Conditions

Healthy

Keywords

Normal, healthy eyes (other than correction for visual acuity)

Outcome Measures

Primary Outcomes (1)

  • Epithelial permeability to fluorescein

Secondary Outcomes (1)

  • tear turnover rate

Study Arms (4)

FID 105783

EXPERIMENTAL
Other: Systane Free lubricant eye drops

Visine

ACTIVE COMPARATOR
Other: Visine Tears Lubricant Eye Drops

Refresh Liquigel

ACTIVE COMPARATOR
Other: Refresh Liquigel Lubricant Eye Drops

Refresh Plus

ACTIVE COMPARATOR
Other: Refresh Plus Lubricant Eye Drops

Interventions

Systane Free lubricant eye dropsOTHER
FID 105783
Visine Tears Lubricant Eye DropsOTHER
Visine
Refresh Liquigel Lubricant Eye DropsOTHER
Refresh Liquigel
Refresh Plus Lubricant Eye DropsOTHER
Refresh Plus

Eligibility Criteria

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

You may qualify if:

  • Ages 18 and over

You may not qualify if:

  • No sodium fluorescein corneal staining at Screening Visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon

Fort Worth, Texas, 76134, United States

Location

Related Publications (1)

  • http://www.aaopt.org/evaluation-new-preservation-system-corneal-barrier-function

    RESULT

MeSH Terms

Interventions

Lubricant Eye Drops

Intervention Hierarchy (Ancestors)

Ophthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Study Officials

  • Mike Christensen

    Alcon Research

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

April 1, 2006

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

November 22, 2016

Record last verified: 2012-02

Locations

US(1)