Observational Study of How Patients Take Eye Drops

Glaucoma Clinical Trial

Official title:

The Relationship Between Glaucoma Medication Self-Efficacy, Outcome Expectations, Eye Drop Tech., Adherence and IOP.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00750646
• Other study ID #: SI-08-54
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2008
• Last updated: September 9, 2008
• Start date: September 2008
• Est. completion date: August 2009

Study information

• Verified date: September 2008
• Source: Robin, Alan L., M.D.
• Contact: Jennifer L Stone, OD
• Phone: 410 377 2422
• Email: jstone[@]glacuomaexpert.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: August 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
United States	Glaucoma Specialists	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Robin, Alan L., M.D.	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence measured by MEMS caps		3 months	No
Primary	Eye drop technique measured by video evaluation		1 time observation	No
Secondary	Medication adherence measured by self-report		3 months	No
Secondary	Severity of VF damage		1 test date	No
Secondary	Intraocular pressure readings		3 months	No