NCT01165164

Brief Summary

The purpose of this study is to describe the night-time use of an investigational lubricant eye drop.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Shorter than 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

June 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

1 month

First QC Date

July 16, 2010

Last Update Submit

January 31, 2012

Conditions

Dry Eye

Keywords

Dry eyeartificial tears

Outcome Measures

Primary Outcomes (1)

  • Nighttime Use Assessment

    Nighttime Use Assessment: "I would use this product at bedtime for my dry eye symptoms" Likert scale (i.e. strongly disagree, disagree, neither disagree nor agree, agree, strongly agree)

    Day 7

Study Arms (1)

FID 115958D

EXPERIMENTAL

Lubricant eye drop

Other: FID 115958D (lubricant eye drop)

Interventions

FID 115958D (lubricant eye drop)OTHER

1 drop in each eye at bedtime

FID 115958D

Eligibility Criteria

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

You may qualify if:

  • Documented diagnosis of dry eye
  • Current use of an eye ointment or tube gel

You may not qualify if:

  • No nighttime contact lenses wear throughout the study period
  • Must not have had punctal plugs inserted within 30 days preceding enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 19, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 2, 2012

Record last verified: 2012-01