Clinical trial NCT01281020: Adherence With Fixed Versus Unfixed Glaucoma Therapy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Open-angle Glaucoma
Ocular Hypertension
Exfoliation Glaucoma
Keywords: Glaucoma
Adherence
Fixed combination therapy
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-01-21
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of adherence
timeFrame: 6 months
Secondary outcomes:
measure: Ocular surface evaluation
timeFrame: 6 months
measure: Treatment satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital
Study officials:
affiliation: Glaucoma Unit, 1st University Department of Ophthalmology
name: Anastasios G Konstas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: