NCT00756093

Brief Summary

To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

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

September 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 11, 2010

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

Same day

First QC Date

September 17, 2008

Results QC Date

September 25, 2009

Last Update Submit

January 31, 2012

Conditions

Keywords

Dry Eye, Artificial Tears,

Outcome Measures

Primary Outcomes (1)

  • Drop Comfort

    Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable.

    once upon instillation

Study Arms (4)

Systane Ultra Lubricant Eye Drops

EXPERIMENTAL

Systane Ultra Lubricant Eye Drops 1 drop each one time

Other: Systane Ultra Lubricant Eye Drops

Optive Lubricant Eye Drops

ACTIVE COMPARATOR

Optive Lubricant Eye Drops 1 drop each eye one time

Other: Optive Lubricant Eye Drops

Blink Tears

ACTIVE COMPARATOR

Blink Tears 1 drop each eye one time

Other: Blink Tears

GenTeal Moderate Lubricant Eye Drops

ACTIVE COMPARATOR

GenTeal Moderate Lubricant Eye Drops 1 drop each eye one time

Other: GenTeal Moderate Lubricant Eye Drops

Interventions

Systane Ultra Lubricant Eye Drops one drop each eye one time

Systane Ultra Lubricant Eye Drops

Optive Lubricant Eye Drops one drop each eye one time

Optive Lubricant Eye Drops

Blink Tears one drop each eye one time

Blink Tears

GenTeal Moderate Lubricant Eye Drops one drop each eye one time

GenTeal Moderate Lubricant Eye Drops

Eligibility Criteria

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

You may qualify if:

  • documented diagnosis of dry eye

You may not qualify if:

  • use of topical ocular drops within 2 hours preceding enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Call Center

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Alcon Clinical
Organization
Alcon Research Ltd

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 19, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 2, 2012

Results First Posted

March 11, 2010

Record last verified: 2012-01

Locations