Observational Study of How Patients Take Eye Drops - Full Text View

Sponsors and Collaborators:	Robin, Alan L., M.D. Alcon Laboratories
Information provided by:	Robin, Alan L., M.D.
ClinicalTrials.gov Identifier:	NCT00750646

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

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	The Relationship Between Glaucoma Medication Self-Efficacy, Outcome Expectations, Eye Drop Tech., Adherence and IOP.

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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.

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

Responsible Party:	Glaucoma Specialists ( Alan L. Robin )
Study ID Numbers:	SI-08-54
Study First Received:	September 9, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00750646
Health Authority:	United States: Institutional Review Board

Keywords provided by Robin, Alan L., M.D.:

compliance
eye drop administration
MEMS
adherence

Study placed in the following topic categories:

Pseudoephedrine
Naphazoline
Oxymetazoline
Guaifenesin
Phenylephrine
Glaucoma

Eye Diseases
Ephedrine
Phenylpropanolamine
Tetrahydrozoline
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Respiratory System Agents
Autonomic Agents
Sympathomimetics
Therapeutic Uses
Physiological Effects of Drugs

Vasoconstrictor Agents
Cardiovascular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Nasal Decongestants

ClinicalTrials.gov processed this record on January 16, 2009