Observational Study of How Patients Take Eye Drops
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Robin, Alan L., M.D..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Robin, Alan L., M.D.
Collaborator:
Alcon Laboratories
Information provided by:
Robin, Alan L., M.D.
ClinicalTrials.gov Identifier:
NCT00750646
First received: September 9, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
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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:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by Robin, Alan L., M.D.:
Primary Outcome Measures:
- Medication adherence measured by MEMS caps [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Eye drop technique measured by video evaluation [ Time Frame: 1 time observation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Medication adherence measured by self-report [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Severity of VF damage [ Time Frame: 1 test date ] [ Designated as safety issue: No ]
- Intraocular pressure readings [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Laboratories
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
No publications provided
| Responsible Party: | Alan L. Robin, Glaucoma Specialists |
| ClinicalTrials.gov Identifier: | NCT00750646 History of Changes |
| Other Study ID Numbers: | SI-08-54 |
| Study First Received: | September 9, 2008 |
| Last Updated: | September 9, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Robin, Alan L., M.D.:
|
compliance eye drop administration MEMS adherence |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Tetrahydrozoline Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013