NCT01105910

Brief Summary

To evaluate the efficacy of Systane Ultra in post menopausal women with dry eye.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 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

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

November 18, 2016

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

April 15, 2010

Last Update Submit

November 17, 2016

Conditions

Post Menopausal Dry Eye Subjects

Keywords

Dry Eye, Post Menopausal dry eye

Outcome Measures

Primary Outcomes (1)

  • Reduction in corneal staining

    30 days

Secondary Outcomes (1)

  • Patient acceptability / comfort

    30 days

Study Arms (2)

Systane Ultra

EXPERIMENTAL

Systane Ultra Lubricant Eye Drops

Other: Systane Ultra Lubricant Eye Drops

Sensitive Eyes

ACTIVE COMPARATOR

Sensitive Eyes Eye Drops (Bausch \& Lomb)

Other: Sensitive Eyes Eye Drops (Bausch & Lomb)

Interventions

Systane Ultra Lubricant Eye DropsOTHER

1 to 2 drops in each eye 4 times per day for 30 days

Systane Ultra
Sensitive Eyes Eye Drops (Bausch & Lomb)OTHER

1 to 2 drops in each eye 4 times per day for 30 days

Sensitive Eyes

Eligibility Criteria

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

You may qualify if:

  • Post-menopausal (menses ceased more than 12 months prior to the start of the study).
  • Diagnosed for dry eye

You may not qualify if:

  • History of Sjögren's Syndrome or evidence of chronic dry eye syndrome. Confirmed autoimmune connective tissue diseases such as rheumatoid arthritis, fibromyalgia or scleroderma.
  • Active and severe blepharitis, rosacea and associated ocular sequelae.
  • Has any significant eyelid abnormality affecting lid function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • http://www.aaopt.org/efficacy-evaluation-systane-ultra-lubricant-eye-drops-postmenopausal-women-dry-eye

    RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2010

First Posted

April 19, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2010

Last Updated

November 18, 2016

Record last verified: 2012-01