Adherence With Fixed Versus Unfixed Glaucoma Therapy
This study has been completed.
Sponsor:
Aristotle University Of Thessaloniki
Collaborator:
Pfizer
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01281020
First received: January 20, 2011
Last updated: January 25, 2013
Last verified: January 2013
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Purpose
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.
| Condition |
|---|
|
Primary Open-angle Glaucoma Ocular Hypertension Exfoliation Glaucoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Aristotle University Of Thessaloniki:
Primary Outcome Measures:
- Rate of adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]Rate of asherence with fixed vs unfixed glaucoma therapy
Secondary Outcome Measures:
- Ocular surface evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]Objective and subjective signs of ocular surface health
- Treatment satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
| Enrollment: | 132 |
| Study Start Date: | May 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Treatment with fixed combination
Patients who receive treatment with latanoprost/timolol fixed combination
|
|
Treatment with unfixed therapy
Patients who receive latanoprost and timolol therapy
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281020
Locations
| Greece | |
| Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital | |
| Thessaloniki, Greece, 546 36 | |
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Pfizer
Investigators
| Principal Investigator: | Anastasios G Konstas, MD, PhD | Glaucoma Unit, 1st University Department of Ophthalmology |
More Information
No publications provided
| Responsible Party: | AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki |
| ClinicalTrials.gov Identifier: | NCT01281020 History of Changes |
| Other Study ID Numbers: | NIS50/01/08 |
| Study First Received: | January 20, 2011 |
| Last Updated: | January 25, 2013 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Aristotle University Of Thessaloniki:
|
Glaucoma Adherence Fixed combination therapy |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Exfoliation Syndrome Eye Diseases Vascular Diseases Cardiovascular Diseases |
Iris Diseases Uveal Diseases Latanoprost Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013