GlaucomaPhase 4NCT00444184
24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost
A Phase 4 study testing Travoprost/timolol fixed combination, travoprost in people with Glaucoma, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. Read more about this study
- Who is it for?
- Ages 29 to 81 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Travoprost/timolol fixed combination, travoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2007to Jan 2008
- Phase
- Phase 4
- 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 29 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00).
- Patient has POAG and is older than 29 years
- The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00)
- Patient can be safely washed out without risk for significant deterioration
- Distance best corrected Snellen visual acuity better than 1/10
- Patient can understand the instructions and comply to medications
- Open normal appearing angles
Who cannot join
- Contraindications to prostaglandins or β-blockers
- History of lack of response (<10% reduction) to any medication
- 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, except blepharitis, corneal abnormality that may affect IOP measurements etc
Trial locations and contacts
1 site in 1 country.
Greece1 site
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, 546 36
About this study
Official title: A Crossover, Double-Masked Comparison Investigating the 24-Hour Intraocular Pressure Control With the Travoprost/Timolol Fixed Combination Versus Travoprost, When Both Are Given in the Evening, in Subjects With Primary Open-Angle Glaucoma
This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.
- Conditions
- Glaucoma
- Being tested
- Travoprost/timolol fixed combination, travoprost
- Keywords
- travoprost/timolol fixed combination
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost/timolol fixed combination, travoprostDrug
| Study group | Role | What they receive |
|---|---|---|
| Travoprost/Timolol therapy | Active comparator | 24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops Receives: Drug: Travoprost/timolol fixed combination, travoprost |
| Travoprost therapy | Active comparator | 24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops Receives: Drug: Travoprost/timolol fixed combination, travoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hour IOP
Measured: 3 months
Secondary outcomes (3)
Mean reduction from baseline
Measured: 3 months
Mean fluctuation of 24-hour IOP
Measured: 3 months
Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, AGP Konstas, Aristotle University Of Thessaloniki
- Investigators
- Anastasios GP Konstas, MD, PhD, Principal investigator, Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444184
- Sponsor's protocol ID
- A3243
- Status last verified
- May 2014
- First submitted
- 5 Mar 2007
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover, Double-Masked Comparison Investigating the 24-Hour Intraocular Pressure Control With the Travoprost/Timolol Fixed Combination Versus Travoprost, When Both Are Given in the Evening, in Subjects With Primary Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00444184
- Acronym / sponsor ID
- A3243
- Conditions
- Glaucoma
- Keywords
- travoprost/timolol fixed combination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Mar 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 7 Mar 2007 (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.
This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Travoprost/Timolol therapy | Active comparator | Drug: Travoprost/timolol fixed combination, travoprost24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops |
| Travoprost therapy | Active comparator | Drug: Travoprost/timolol fixed combination, travoprost24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops |
Who may qualify
- Ages
- 29 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00).
- Patient has POAG and is older than 29 years
- The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00)
- Patient can be safely washed out without risk for significant deterioration
- Distance best corrected Snellen visual acuity better than 1/10
Key exclusion criteria (5 listed)
- Contraindications to prostaglandins or β-blockers
- History of lack of response (<10% reduction) to any medication
- 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, except blepharitis, corneal abnormality that may affect IOP measurements etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Travoprost/timolol fixed combination, travoprost | Drug | Travoprost therapy, Travoprost/Timolol therapy |
Primary outcome
Mean 24-hour IOP
Time frame: 3 months
3 secondary outcomes
Mean reduction from baseline
Time frame: 3 months
Mean fluctuation of 24-hour IOP
Time frame: 3 months
Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.
Time frame: 3 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 12 May 2014.
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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 GP Konstas, MD, PhD principal investigator
Associate Professor and Head of the 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?
A Phase 4 study testing Travoprost/timolol fixed combination, travoprost in people with Glaucoma, 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 5 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 12 May 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean 24-hour IOP (time frame: 3 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 12 May 2014.