Observational Study of How Patients Take Eye Drops
The Relationship Between Glaucoma Medication Self-Efficacy, Outcome Expectations, Eye Drop Tech., Adherence and IOP.
1 other identifier
observational
220
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 9, 2008
CompletedFirst Posted
Study publicly available on registry
September 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedSeptember 10, 2008
September 1, 2008
6 months
September 9, 2008
September 9, 2008
Conditions
Keywords
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.
Interventions
The Medication Event Monitoring System will be used to assess the level of subject adherence to recommended topical eye drop therapy.
Eligibility Criteria
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
- Robin, Alan L., M.D.lead
- Alcon Researchcollaborator
Study Sites (1)
Glaucoma Specialists
Baltimore, Maryland, 21209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer L Stone, OD
Glaucoma Experts
- PRINCIPAL INVESTIGATOR
Alan L Robin, MD
Glaucoma Specialists
- STUDY DIRECTOR
Colleen K Protzko
Glaucoma Specialists
Central Study Contacts
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