NCT00750646

Brief Summary

This study is interested in monitoring how patients take eye drops, both through video-recordings and adherence monitoring, as well as their perceptions about their eye medications; including the dosing schedules, instillation techniques and effect on their disease.

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
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Shorter than P25 for all trials

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

September 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 10, 2008

Status Verified

September 1, 2008

Enrollment Period

6 months

First QC Date

September 9, 2008

Last Update Submit

September 9, 2008

Conditions

Keywords

complianceeye drop administrationMEMSadherence

Outcome Measures

Primary Outcomes (2)

  • Medication adherence measured by MEMS caps

    3 months

  • Eye drop technique measured by video evaluation

    1 time observation

Secondary Outcomes (3)

  • Medication adherence measured by self-report

    3 months

  • Severity of VF damage

    1 test date

  • Intraocular pressure readings

    3 months

Study Arms (1)

A

Subject's adherence to prescribed therapy will be monitored with an electronic compliance device.

Device: MEMS cap

Interventions

MEMS capDEVICE

The Medication Event Monitoring System will be used to assess the level of subject adherence to recommended topical eye drop therapy.

Also known as: MEMS
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be enrolled for a single site, private practice.

You may qualify if:

  • \>18 year old
  • currently taking 1 or more hypotensive topical eye drops takes drops in the right eye for more than 6 months expect to continue drop use for the next 3 months
  • subjects instill their own eye drops
  • subject is able to take HVF tests
  • subject will expect to complete the 3 months enrollment period

You may not qualify if:

  • unable/unwilling to instill own medications
  • eye drops are discontinued
  • unable to take HVF test
  • unable to complete follow-up
  • investigators discontinue subject for safety reasons
  • not using drops in left eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaucoma Specialists

Baltimore, Maryland, 21209, United States

RECRUITING

MeSH Terms

Conditions

GlaucomaPatient Compliance

Interventions

Micro-Electrical-Mechanical Systems

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Jennifer L Stone, OD

    Glaucoma Experts

    PRINCIPAL INVESTIGATOR
  • Alan L Robin, MD

    Glaucoma Specialists

    PRINCIPAL INVESTIGATOR
  • Colleen K Protzko

    Glaucoma Specialists

    STUDY DIRECTOR

Central Study Contacts

Jennifer L Stone, OD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 10, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2009

Study Completion

August 1, 2009

Last Updated

September 10, 2008

Record last verified: 2008-09

Locations