Observational Study of How Patients Take Eye Drops

September 9, 2008 updated by: Robin, Alan L., M.D.

The Relationship Between Glaucoma Medication Self-Efficacy, Outcome Expectations, Eye Drop Tech., Adherence and IOP.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Recruiting
        • Glaucoma Specialists
        • Contact:
        • Contact:
          • Millie Brummett
          • Phone Number: 4103772422
        • Principal Investigator:
          • Jennifer L Stone, OD
        • Sub-Investigator:
          • Alan L Robin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • >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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Subject's adherence to prescribed therapy will be monitored with an electronic compliance device.
Device: MEMS cap
The Medication Event Monitoring System will be used to assess the level of subject adherence to recommended topical eye drop therapy.
Other Names:
  • MEMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medication adherence measured by MEMS caps
Time Frame: 3 months
3 months
Eye drop technique measured by video evaluation
Time Frame: 1 time observation
1 time observation

Secondary Outcome Measures

Outcome Measure
Time Frame
Medication adherence measured by self-report
Time Frame: 3 months
3 months
Severity of VF damage
Time Frame: 1 test date
1 test date
Intraocular pressure readings
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robin, Alan L., M.D.

Collaborators

Alcon Research

Investigators

  • Principal Investigator: Jennifer L Stone, OD, Glaucoma Experts
  • Principal Investigator: Alan L Robin, MD, Glaucoma Specialists
  • Study Director: Colleen K Protzko, Glaucoma Specialists

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

March 1, 2009

Study Completion (Anticipated)

August 1, 2009

Study Registration Dates

First Submitted

September 9, 2008

First Submitted That Met QC Criteria

September 9, 2008

First Posted (Estimate)

September 10, 2008

Study Record Updates

Last Update Posted (Estimate)

September 10, 2008

Last Update Submitted That Met QC Criteria

September 9, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI-08-54

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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