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Observational Study of How Patients Take Eye Drops

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. Identifier: NCT00750646
Recruitment Status : Unknown
Verified September 2008 by Robin, Alan L., M.D..
Recruitment status was:  Recruiting
First Posted : September 10, 2008
Last Update Posted : September 10, 2008
Alcon Research
Information provided by:
Robin, Alan L., M.D.

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.

Condition or disease Intervention/treatment
Glaucoma Device: MEMS cap

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship Between Glaucoma Medication Self-Efficacy, Outcome Expectations, Eye Drop Tech., Adherence and IOP.
Study Start Date : September 2008
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00750646

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

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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
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Principal Investigator: Jennifer L Stone, OD Glaucoma Experts
Principal Investigator: Alan L Robin, MD Glaucoma Specialists
Study Director: Colleen K Protzko Glaucoma Specialists
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Responsible Party: Alan L. Robin, Glaucoma Specialists Identifier: NCT00750646    
Other Study ID Numbers: SI-08-54
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: September 10, 2008
Last Verified: September 2008
Keywords provided by Robin, Alan L., M.D.:
eye drop administration
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases