NCT01227226

Brief Summary

The effect of artificial tears on tear osmolarity

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 7, 2011

Status Verified

February 1, 2011

Enrollment Period

5 months

First QC Date

October 21, 2010

Last Update Submit

February 4, 2011

Conditions

Dry Eye

Keywords

Dry eye

Outcome Measures

Primary Outcomes (1)

  • Tear osmolarity

    Tear osmolarity measured with TearLab instrument

    2 days

Study Arms (4)

Refresh tears

ACTIVE COMPARATOR

Allergan's Refresh tears artificial tear

Drug: Artificial tears

Systane Ultra

ACTIVE COMPARATOR

Alcon's Systane Ultra artificial tear

Drug: Artificial tears

Visine

ACTIVE COMPARATOR

Visine artificial tear

Drug: Artificial tears

Blink tears

ACTIVE COMPARATOR

AMO's blink tears artificial tear

Drug: Artificial tears

Interventions

Artificial tearsDRUG

Instill one drop of artificial tears

Also known as: Allergan's Refresh tears, Alcon's Systane Ultra, Johnson and Johnson's Visine, AMO's blink tears
Blink tearsRefresh tearsSystane UltraVisine

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 18 and over inclusive. Males or females Any race or ethnic background Patient is in generally good \& stable overall health. Patient likely to comply with study guidelines \& study visits. Informed consent signed. Subjective evaluation of symptom of dryness (SESoD): Score 2 (Mild)

You may not qualify if:

  • Corneal refractive surgery within 6 months of this study. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
  • Corneal staining Grade 3 or higher No Restasis for past 3 months Discontinue topical medications for at least 1 week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Milton M. Hom, OD, FAAO.

Azusa, California, 91702, United States

Location

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 Officials

  • Milton M Hom, OD FAAO

    Private Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

October 21, 2010

First Posted

October 25, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

February 7, 2011

Record last verified: 2011-02

Locations

US(1)