NCT01335126

Brief Summary

The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.

Trial Health

35
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 below P25 for phase_3

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3

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

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

April 14, 2011

Status Verified

April 1, 2011

Enrollment Period

7 months

First QC Date

April 12, 2011

Last Update Submit

April 13, 2011

Conditions

Dry Eye

Keywords

Artificial tears

Outcome Measures

Primary Outcomes (1)

  • Tolerability Questionnaire

    Tolerability (comfort) measured with Visual Analog scale (1 to 100)

    8 weeks

Secondary Outcomes (2)

  • Acceptability Questionnaire

    8 weeks

  • Tear Break Up Time

    2-3 weeks

Study Arms (1)

Test

EXPERIMENTAL
Other: Emulsion type artificial tear

Interventions

Emulsion type artificial tearOTHER

2 types of artificial tears

Test

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
  • Patient is in generally good \& stable overall health.
  • Patient likely to comply with study guidelines \& study visits.
  • Informed consent signed.
  • OSDI score \>18 OR
  • TBUT \<10 seconds

You may not qualify if:

  • Corneal refractive surgery or contact lens wear within 6 months of this study.
  • Current use of Restasis
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Milton M Hom, OD FAAO

    Private Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV

Study Record Dates

First Submitted

April 12, 2011

First Posted

April 14, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

April 14, 2011

Record last verified: 2011-04