COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Adherence With Fixed Versus Unfixed Glaucoma Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01281020
Recruitment Status : Completed
First Posted : January 21, 2011
Last Update Posted : May 12, 2014
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki

Brief Summary:
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 or disease
Primary Open-angle Glaucoma Ocular Hypertension Exfoliation Glaucoma

Layout table for study information
Study Type : Observational
Actual Enrollment : 132 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011

Treatment with fixed combination
Patients who receive treatment with latanoprost/timolol fixed combination
Treatment with unfixed therapy
Patients who receive latanoprost and timolol therapy

Primary Outcome Measures :
  1. Rate of adherence [ Time Frame: 6 months ]
    Rate of asherence with fixed vs unfixed glaucoma therapy

Secondary Outcome Measures :
  1. Ocular surface evaluation [ Time Frame: 6 months ]
    Objective and subjective signs of ocular surface health

  2. Treatment satisfaction [ Time Frame: 6 months ]
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01281020

Layout table for location information
Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital
Thessaloniki, Greece, 546 36
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Layout table for investigator information
Principal Investigator: Anastasios G Konstas, MD, PhD Glaucoma Unit, 1st University Department of Ophthalmology
Layout table for additonal information
Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki Identifier: NCT01281020    
Other Study ID Numbers: NIS50/01/08
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014
Keywords provided by AGP Konstas, Aristotle University Of Thessaloniki:
Fixed combination therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma, Open-Angle
Ocular Hypertension
Exfoliation Syndrome
Eye Diseases
Iris Diseases
Uveal Diseases