NCT01086774

Brief Summary

Evaluation of the optical effects of Systane Ultra

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4

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

First Submitted

Initial submission to the registry

March 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

4 months

First QC Date

March 12, 2010

Last Update Submit

January 31, 2012

Conditions

Dry Eye

Keywords

Dry eyeTear Film Stability

Outcome Measures

Primary Outcomes (1)

  • Improvement in maximum blink interval (MBI)

    1 day

Secondary Outcomes (1)

  • Tear film stability and contrast sensitivity

    1 day

Study Arms (1)

Systane Ultra

EXPERIMENTAL

Systane Ultra Lubricant Eye Drops

Other: Systane Ultra Lubricant Eye Drops

Interventions

Systane Ultra Lubricant Eye DropsOTHER

Single drop in both eyes

Systane Ultra

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or more.
  • Subjects must have Tear Break Up Time (TBUT) \< 5 seconds
  • Subjects must have a maximum blink interval (MBI) \< 10 seconds
  • Subjects must be willing to comply with all study requirements.
  • Subjects must understand, sign and be given a copy of the written Informed Consent form.

You may not qualify if:

  • Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
  • Subjects with known sensitivity to planned study concomitant medications
  • Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
  • Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 15, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2010

Last Updated

February 2, 2012

Record last verified: 2012-01