Adherence With Fixed Versus Unfixed Glaucoma Therapy

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281020
• Other study ID #: NIS50/01/08
• Status: Completed
• Start date: May 2009
• Est. completion date: July 2011

Study information

• Verified date: December 2020
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Exfoliation Glaucoma
• Exfoliation Syndrome
• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Primary Open-angle Glaucoma

Locations

Country	Name	City	State
Greece	Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Pfizer

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adherence	Rate of asherence with fixed vs unfixed glaucoma therapy	6 months
Secondary	Ocular surface evaluation	Objective and subjective signs of ocular surface health	6 months
Secondary	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