NCT00568386

Brief Summary

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

Trial Health

100
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

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable

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

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 10, 2010

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

First QC Date

December 5, 2007

Results QC Date

December 18, 2008

Last Update Submit

January 31, 2012

Conditions

Keywords

Dry eye

Outcome Measures

Primary Outcomes (1)

  • Visual Blur

    Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.

    3 minutes post dose

Study Arms (2)

Systane Lubricant Eye Drops

EXPERIMENTAL

Systane Lubricant Eye Drops 1 drop in each eye one time

Other: Systane Lubricant Eye Drops

Optive Lubricant Eye Drops

ACTIVE COMPARATOR

Optive Lubricant Eye Drops 1 drop each one time

Other: Optive Lubricant Eye Drops

Interventions

Systane Lubricant Eye Drops 1 drop each eye once time

Systane Lubricant Eye Drops

Optive Lubricant Eye Drops 1 drop each eye one time

Optive Lubricant Eye Drops

Eligibility Criteria

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

You may qualify if:

  • Healthy, normal eyes OR documented diagnosis of dry eye

You may not qualify if:

  • Must not have worn contact lenses for 7 days preceding enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Alcon Clinical
Organization
Alcon Research

Study Officials

  • Mike Christensen

    Alcon Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 6, 2007

Study Start

November 1, 2007

Study Completion

December 1, 2007

Last Updated

February 2, 2012

Results First Posted

March 10, 2010

Record last verified: 2012-01