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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
Sponsor:
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

September 9, 2008
September 9, 2008
September 2008
March 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Observational Study of How Patients Take Eye Drops
The Relationship Between Glaucoma Medication Self-Efficacy, Outcome Expectations, Eye Drop Tech., Adherence and IOP.

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects will be enrolled for a single site, private practice.
Glaucoma
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
A
Subject's adherence to prescribed therapy will be monitored with an electronic compliance device.
Intervention: Device: MEMS cap
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
August 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Jennifer L Stone, OD 410 377 2422 jstone@glacuomaexpert.com
Contact: Colleen K Protzko 4103772422 cprotzko@glaucomaexpert.com
United States
 
NCT00750646
SI-08-54
Yes
Alan L. Robin, Glaucoma Specialists
Robin, Alan L., M.D.
Alcon Laboratories
Principal Investigator: Jennifer L Stone, OD Glaucoma Experts
Principal Investigator: Alan L Robin, MD Glaucoma Specialists
Study Director: Colleen K Protzko Glaucoma Specialists
Robin, Alan L., M.D.
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP