Adherence With Fixed Versus Unfixed Glaucoma Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Primary Open-angle Glaucoma; Exfoliation Glaucoma

• Study Type: Observational
• Enrollment (Actual): 132

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 546 36
    • Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adherence	Rate of asherence with fixed vs unfixed glaucoma therapy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular surface evaluation	Objective and subjective signs of ocular surface health	6 months
Treatment satisfaction	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.	6 months

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Collaborators: Pfizer
• Investigators: Principal Investigator: Anastasios G Konstas, MD, PhD, Glaucoma Unit, 1st University Department of Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 20, 2011
• First Posted (Estimate): January 21, 2011

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Adherence; Glaucoma; Fixed combination therapy
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Iris Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Exfoliation Syndrome
• Other Study ID Numbers: NIS50/01/08