NCT00983203

Brief Summary

The purpose of this study is to describe the acute comfort and haze profile of FID 114657 in dry eye patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below 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

July 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2009

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

1 month

First QC Date

September 23, 2009

Last Update Submit

January 31, 2012

Conditions

Keywords

Dry eyeartificial tears

Outcome Measures

Primary Outcomes (1)

  • Drop comfort upon instillation

    Upon instillation

Study Arms (2)

FID 114657

EXPERIMENTAL

FID 114657

Other: FID 114657 ORB Preserved Ocular Emulsion

Soothe XP Lubricant Eye Drops

ACTIVE COMPARATOR

Soothe XP Lubricant Eye Drops

Other: Soothe XP Lubricant Eye Drops

Interventions

1 drop OU

Soothe XP Lubricant Eye Drops

Eligibility Criteria

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

You may qualify if:

  • Documented diagnosis of dry eye

You may not qualify if:

  • Must not have worn contact lenses for 1 week preceding enrollment

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
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 24, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2009

Last Updated

February 2, 2012

Record last verified: 2012-01