Observational Study of How Patients Take Eye Drops

NCT ID: NCT00750646

Last Updated: 2008-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma

Keywords

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compliance eye drop administration MEMS adherence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Subject's adherence to prescribed therapy will be monitored with an electronic compliance device.

MEMS cap

Intervention Type DEVICE

The Medication Event Monitoring System will be used to assess the level of subject adherence to recommended topical eye drop therapy.

Interventions

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MEMS cap

The Medication Event Monitoring System will be used to assess the level of subject adherence to recommended topical eye drop therapy.

Intervention Type DEVICE

Other Intervention Names

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MEMS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Robin, Alan L., M.D.

INDIV

Sponsor Role lead

Responsible Party

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Glaucoma Specialists

Principal Investigators

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Jennifer L Stone, OD

Role: PRINCIPAL_INVESTIGATOR

Glaucoma Experts

Alan L Robin, MD

Role: PRINCIPAL_INVESTIGATOR

Glaucoma Specialists

Colleen K Protzko

Role: STUDY_DIRECTOR

Glaucoma Specialists

Locations

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Glaucoma Specialists

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer L Stone, OD

Role: CONTACT

Phone: 410 377 2422

Email: [email protected]

Colleen K Protzko

Role: CONTACT

Phone: 4103772422

Email: [email protected]

Facility Contacts

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Colleen K Protzko

Role: primary

Millie Brummett

Role: backup

Other Identifiers

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SI-08-54

Identifier Type: -

Identifier Source: org_study_id