NCT00748865

Brief Summary

To evaluate drop comfort, acceptability, preference and blue profile between two marketed artificial tears in both dry eyes and non-dry eye patient population.

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 Jul 2008

Shorter than P25 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

July 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 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

1 month

First QC Date

September 5, 2008

Results QC Date

September 25, 2009

Last Update Submit

January 31, 2012

Conditions

Dry Eye

Keywords

Dry EyeArtificial 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 (2)

Systane Ultra

EXPERIMENTAL

Systane Ultra 1 drop each eye one time

Other: Systane Ultra Lubricant Eye Drops

Systane

ACTIVE COMPARATOR

Systane 1 drop each eye one time

Other: Systane Lubricant Eye Drops

Interventions

Systane Ultra Lubricant Eye DropsOTHER

Systane Ultra Lubricant Eye Drops 1 drop each eye one time

Systane Ultra
Systane Lubricant Eye DropsOTHER

Systane Lubricant Eye Drops 1 drop each eye one time

Systane

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 contact lens within 7 days preceding enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Location

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Alcon Clinical
Organization
Alcon Research Ltd.
medinfo@alconlabs.com
888.451.3937; 817.568.6725

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 5, 2008

First Posted

September 9, 2008

Study Start

July 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

February 2, 2012

Results First Posted

March 11, 2010

Record last verified: 2012-01

Locations

US(1)