Adherence With Fixed Versus Unfixed Glaucoma Therapy

Completed

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

• Registration Number: NCT01281020
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-21
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of adherence	6 months	Rate of asherence with fixed vs unfixed glaucoma therapy

Secondary Outcome Measures

Name	Time	Method
Ocular surface evaluation	6 months	Objective and subjective signs of ocular surface health
Treatment satisfaction	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.

Trial Locations

Locations (1)

Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital; 🇬🇷 Thessaloniki, Greece