NCT01417013

Brief Summary

The primary objective of this study is assess the Tear Film break-up time (TBUT) in mild to moderate dry eye subjects.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Status
withdrawn

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, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

6 months

First QC Date

August 12, 2011

Last Update Submit

February 6, 2012

Conditions

Dry Eye

Keywords

Dry eye or lubricant eye drops

Outcome Measures

Primary Outcomes (1)

  • TBUT

    Tear Film break-up time

    14 Days

Study Arms (2)

Systane Ultra

ACTIVE COMPARATOR

Systane Ultra Lubricant Eye Drops

Other: Systane Ultra

Optive

ACTIVE COMPARATOR

Optive Lubricant eye drops

Other: Optive

Interventions

Systane UltraOTHER

Lubricant Eye Drops

Also known as: Systane Ultra Lubricant Eye Drops
Systane Ultra
OptiveOTHER

Lubricant eye drops

Also known as: Optive Lubricant eye drops
Optive

Eligibility Criteria

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

You may qualify if:

  • Corrected VA of 0.6 LogMar or better OU

You may not qualify if:

  • Topical ocular medication use
  • Presence of Ocular conditions (blepharitis, conjunctival infections, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases
0

Study Design

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

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 16, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 8, 2012

Record last verified: 2012-02