NCT01030237

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ 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

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

February 2, 2012

Status Verified

February 1, 2012

Enrollment Period

2 months

First QC Date

December 10, 2009

Last Update Submit

February 1, 2012

Conditions

Dry Eye

Keywords

Dry eyeartificial tears

Outcome Measures

Primary Outcomes (3)

  • Tear Break-Up Time (TBUT)

    measured at Days 0, 7, 14, 28 and 42

  • Corneal Staining

    measured at Days 0, 7, 14, 28 and 42

  • Conjunctival Staining

    measured at Days 0, 7, 14, 28 and 42

Study Arms (2)

FID 114657

EXPERIMENTAL

FID 114657

Other: FID 114657

Soothe XP Lubricant Eye Drops

ACTIVE COMPARATOR

Soothe XP Lubricant Eye Drops

Other: Soothe XP Lubricant Eye Drops

Interventions

FID 114657OTHER

1 drop both eyes four times a day for 6 weeks

FID 114657
Soothe XP Lubricant Eye DropsOTHER

1 drop both eyes four times a day for 6 weeks

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
  • NaFl Corneal Staining sum score ≥ 3 in either 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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2009

First Posted

December 11, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2010

Last Updated

February 2, 2012

Record last verified: 2012-02