Primary Open-angle GlaucomaNCT01281020
Adherence With Fixed Versus Unfixed Glaucoma Therapy
An observational study of Primary Open-angle Glaucoma and Ocular Hypertension, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Open-angle Glaucoma, Ocular Hypertension, Exfoliation Glaucoma
- How many people
- 132 participants
- Where
- 1 siteGreece
- Study dates
- May 2009to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital
Thessaloniki, 546 36
About this study
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
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.
- Keywords
- Glaucoma, Adherence, Fixed combination therapy
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Exfoliation Syndrome, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with fixed combination | Patients who receive treatment with latanoprost/timolol fixed combination | |
| Treatment with unfixed therapy | Patients who receive latanoprost and timolol therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adherence
Rate of asherence with fixed vs unfixed glaucoma therapy
Measured: 6 months
Secondary outcomes (2)
Ocular surface evaluation
Objective and subjective signs of ocular surface health
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startMay 2009
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, AGP Konstas, Aristotle University Of Thessaloniki
- Investigators
- Anastasios G Konstas, MD, PhD, Principal investigator, Glaucoma Unit, 1st University Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281020
- Sponsor's protocol ID
- NIS50/01/08
- Status last verified
- Dec 2020
- First submitted
- 20 Jan 2011
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01281020
- Acronym / sponsor ID
- NIS50/01/08
- Keywords
- Glaucoma, Adherence, Fixed combination therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2009 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with fixed combination | – | –Patients who receive treatment with latanoprost/timolol fixed combination |
| Treatment with unfixed therapy | – | –Patients who receive latanoprost and timolol therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of adherence
Time frame: 6 months
Rate of asherence with fixed vs unfixed glaucoma therapy
2 secondary outcomes
Ocular surface evaluation
Time frame: 6 months
Treatment satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anastasios G Konstas, MD, PhD principal investigator
Glaucoma Unit, 1st University Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open-angle Glaucoma and Ocular Hypertension, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.