Adherence With Fixed Versus Unfixed Glaucoma Therapy

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01281020
First received: January 20, 2011
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

A 6-month, parallel, non-interventional trial investigating the level of adherence and the impact of dosing in open-angle glaucoma patients who receive either unfixed therapy with latanoprost once in the evening and timolol twice daily, or latanoprost/timolol fixed combination therapy once in the evening. All patients participating in this observational study will be monitored for their adherence with the use of Medication Event Monitoring System (MEMS). At the end of treatment periods treatment satisfaction will be assessed with selected questions from the Treatment Satisfaction Survey-Intraocular Pressure survey. This study will monitor objectively, for the first time, adherence and intraocular pressure control with fixed versus unfixed therapy. Finally it will help us to elucidate the impact of dosing (once-a-day versus three-times-daily) on the level of adherence in glaucoma.


Condition
Primary Open-angle Glaucoma
Ocular Hypertension
Exfoliation Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 3-month, Observational Study Investigating With Electronic Monitoring the Level of Adherence and Treatment Satisfaction With Latanoprost/Timolol Fixed Combination Versus Unfixed Therapy in Open-angle Glaucoma

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Rate of adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rate of asherence with fixed vs unfixed glaucoma therapy


Secondary Outcome Measures:
  • Ocular surface evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Objective and subjective signs of ocular surface health

  • Treatment satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To document satisfaction with therapy this study will employ questions selected from a validated treatment satisfaction questionnaire (questions 10-15, Treatment Satisfaction Survey-Intraocular Pressure) as published by Day et al (Eye 2006; 20: 583-590). The survey will assess the level of satisfaction and overall quality-of-life with latanoprost/timolol fixed combination versus unfixed therapy in this study.


Enrollment: 132
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Treatment with fixed combination
Patients who receive treatment with latanoprost/timolol fixed combination
Treatment with unfixed therapy
Patients who receive latanoprost and timolol therapy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients who use latanoprost/timolol fixed combination therapy with once-a-day dosing in the evening

All patients already treated with timolol twice daily and latanoprost once in the evening

Criteria

Inclusion Criteria:

  • Patient is between 21-80 years old
  • Patient has ocular hypertension or open-angle glaucoma Patient receives therapy and is well controlled on fixed or unfixed latanoprost and timolol therapy
  • Untreated IOP >19 mm Hg <33 mm Hg at baseline (10:00 hour)
  • Open normal appearing angles
  • Patient had at least a 20% reduction vs untreated baseline on current therapy
  • Patient has early or moderate glaucoma (< 14 decibel; 0.8 or better cupping)
  • Distance best corrected Snellen visual acuity greater than 1/10

Exclusion Criteria:

  • Contraindication to timolol or prostaglandin therapy
  • History of lack of response to any medication (< 10%)
  • Patient does not understand the instructions and will not comply to medications
  • Patient can not attend follow up
  • Patient is a female of childbearing potential, or lactating mother
  • History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
  • Sign of ocular infection
  • A corneal abnormality that may affect IOP measurements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281020

Locations
Greece
Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital
Thessaloniki, Greece, 546 36
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Pfizer
Investigators
Principal Investigator: Anastasios G Konstas, MD, PhD Glaucoma Unit, 1st University Department of Ophthalmology
  More Information

No publications provided

Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01281020     History of Changes
Other Study ID Numbers: NIS50/01/08
Study First Received: January 20, 2011
Last Updated: May 9, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:
Glaucoma
Adherence
Fixed combination therapy

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Exfoliation Syndrome
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Iris Diseases
Uveal Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014