Observational Study of How Patients Take Eye Drops | NCT00750646

Studies
Observational Study of How Patients Take Eye Drops

NCT00750646

Sponsor

Robin, Alan L., M.D.

Status

Unknown status

Last Update Posted

Sep 10, 2008Estimated

Enrollment

220Estimated

Phase

Not provided

Conditions

Glaucoma

Interventions

MEMS cap

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Mar 2009Estimated

Completion Date

Aug 2009Estimated

First Submitted Date

Sep 9, 2008

First Submission Date that Met QC Criteria

Sep 9, 2008

First Posted Date

Sep 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2008

Last Update Posted Date

Sep 10, 2008Estimated

Name	Class
Alcon Research	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		Subject's adherence to prescribed therapy will be monitored with an electronic compliance device.	Device: MEMS cap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MEMS cap	Device	The Medication Event Monitoring System will be used to assess the level of subject adherence to recommended topical eye drop therapy.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medication adherence measured by MEMS caps		3 months
Eye drop technique measured by video evaluation		1 time observation

Secondary Outcomes

Measure	Description	Time Frame
Medication adherence measured by self-report		3 months
Severity of VF damage		1 test date
Intraocular pressure readings

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects will be enrolled for a single site, private practice.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jennifer L Stone, OD	Contact	410 377 2422		jstone@glacuomaexpert.com
Colleen K Protzko	Contact	4103772422		cprotzko@glaucomaexpert.com

Overall Officials

Name	Affiliation	Role
Jennifer L Stone, OD	Glaucoma Experts	Principal Investigator
Alan L Robin, MD	Glaucoma Specialists	Principal Investigator
Colleen K Protzko

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glaucoma Specialists	Recruiting	Baltimore	Maryland	21209	United States

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D010349	Patient Compliance

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055617	Micro-Electrical-Mechanical Systems

Ancestor Terms

ID	Term
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided