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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
Alcon Research
Information provided by:
Robin, Alan L., M.D. Identifier:
First received: September 9, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
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
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


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00750646

Contact: Jennifer L Stone, OD 410 377 2422
Contact: Colleen K Protzko 4103772422

United States, Maryland
Glaucoma Specialists Recruiting
Baltimore, Maryland, United States, 21209
Contact: Colleen K Protzko    410-377-2422   
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
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 Identifier: NCT00750646     History of Changes
Other Study ID Numbers: SI-08-54
Study First Received: September 9, 2008
Last Updated: September 9, 2008

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

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents processed this record on June 23, 2017