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Observational Study of How Patients Take Eye Drops

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by Robin, Alan L., M.D..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00750646
First Posted: September 10, 2008
Last Update Posted: September 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alcon Research
Information provided by:
Robin, Alan L., M.D.
  Purpose
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.

Condition Intervention
Glaucoma Device: MEMS cap

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship Between Glaucoma Medication Self-Efficacy, Outcome Expectations, Eye Drop Tech., Adherence and IOP.

Resource links provided by NLM:


Further study details as provided by Robin, Alan L., M.D.:

Primary Outcome Measures:
  • Medication adherence measured by MEMS caps [ Time Frame: 3 months ]
  • Eye drop technique measured by video evaluation [ Time Frame: 1 time observation ]

Secondary Outcome Measures:
  • Medication adherence measured by self-report [ Time Frame: 3 months ]
  • Severity of VF damage [ Time Frame: 1 test date ]
  • Intraocular pressure readings [ Time Frame: 3 months ]

Estimated Enrollment: 220
Study Start Date: September 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: MEMS

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be enrolled for a single site, private practice.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750646


Contacts
Contact: Jennifer L Stone, OD 410 377 2422 jstone@glacuomaexpert.com
Contact: Colleen K Protzko 4103772422 cprotzko@glaucomaexpert.com

Locations
United States, Maryland
Glaucoma Specialists Recruiting
Baltimore, Maryland, United States, 21209
Contact: Colleen K Protzko    410-377-2422    cprotzko@glaucomaexpert.com   
Contact: Millie Brummett    4103772422      
Principal Investigator: Jennifer L Stone, OD         
Sub-Investigator: Alan L Robin, MD         
Sponsors and Collaborators
Robin, Alan L., M.D.
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
  More Information

Responsible Party: Alan L. Robin, Glaucoma Specialists
ClinicalTrials.gov Identifier: NCT00750646     History of Changes
Other Study ID Numbers: SI-08-54
First Submitted: September 9, 2008
First Posted: September 10, 2008
Last Update Posted: September 10, 2008
Last Verified: September 2008

Keywords provided by Robin, Alan L., M.D.:
compliance
eye drop administration
MEMS
adherence

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Tetrahydrozoline
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents