NCT00673764

Brief Summary

To evaluate the effect of 2 different lubricant eye drops on visual function of patients with dry eye

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

May 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 10, 2010

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

1 month

First QC Date

May 2, 2008

Results QC Date

September 18, 2009

Last Update Submit

January 31, 2012

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Time at Best Corrected Visual Acuity

    Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.

    15 minutes, 45 minutes, and 90 minutes post-dose

Secondary Outcomes (1)

  • Functional Blink Rate Time (Time Between Blinks)

    15 minutes, 45 minutes, and 90 minutes post-dose

Study Arms (2)

Systane Ultra

EXPERIMENTAL

Systane Ultra Lubricant Eye Drops

Other: Systane Ultra Lubricant Eye Drops

Optive

ACTIVE COMPARATOR

Optive Lubricant Eye Drops

Other: Optive Lubricant Eye Drops

Interventions

Systane Ultra Lubricant Eye DropsOTHER

Systane Ultra Lubricant Eye Drops 1 drop each eye one time

Systane Ultra
Optive Lubricant Eye DropsOTHER

Optive Lubricant Eye Drops 1 drop each eye one time

Optive

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of dry eye
  • Must not have worn contact lenses for 12 hours prior to Day 1

You may not qualify if:

  • Age related

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Andover

North Andover, Massachusetts, 01845, 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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2008

First Posted

May 7, 2008

Study Start

May 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 2, 2012

Results First Posted

February 10, 2010

Record last verified: 2012-01

Locations

US(1)