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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01281020
Other study ID # NIS50/01/08
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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