GlaucomaPhase 4NCT01779284
Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy
A Phase 4 study testing Travoprost/timolol therapy and Latanoprost/Timolol therapy in people with Glaucoma, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. Read more about this study
- Who is it for?
- Ages 29 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Travoprost/timolol therapy and Latanoprost/Timolol therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2012to Jan 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary open-angle glaucoma or exfoliative glaucoma
- Patients who require additional IOP lowering on latanoprost monotherapy
- Morning IOP greater than 20 mm Hg on latanoprost monotherapy
- Untreated morning IOP greater than 26 mm Hg
- Patients older than 29 years
- Patients with early to moderate glaucoma (less than 14 decibel (dB) mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio)
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- On therapy with latanoprost monotherapy for at least 3 months
- Patients with a reliable visual field
- Best corrected distance Snellen visual acuity >1/10
- Corneal pachymetry within the 550 ± 50 μm range
- Patients should understand the study instructions
- Patients willing to attend all follow-up appointments and willing to comply with study medication usage
- Patients who have open, normal appearing angles
Who cannot join
- History of combined topical therapy
- Contraindication to prostaglandins or timolol
- History of ocular trauma or inflammation; intraocular surgery; severe dry eyes; use of contact lenses
- Sign of ocular infection except for mild blepharitis
- Any corneal abnormality that could have affected the measurement of IOP
- Chronic use of topical corticosteroids in the last 3 months before entering the study
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- Current, or previous use of systemic corticosteroid treatment
- Uncontrolled systemic disease
- Change of a systemic medication during the study period
- Women of childbearing potential or lactating mothers
- Inability to understand the instructions and adhere to medications
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: 24-Hour Efficacy of Travoprost/Timolol Benzalkonium Chloride BAK Free Compared With Latanoprost/Timolol Fixed Combination Therapy in Subjects With Open-Angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy
The primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium chloride given once in the evening, versus the latanoprost/timolol fixed combination given in the evening. It is assumed that travoprost/timolol fixed combination will provide better quality of 24-hour pressure control.
- Conditions
- Glaucoma
- Being tested
- Travoprost/timolol therapy, Latanoprost/Timolol therapy
- Keywords
- glaucoma, fixed combinations, 24-hour monitoring
- 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 therapyDrug
Also called DuoTrav BAK Free
Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing
Latanoprost/Timolol therapyDrug
Also called Xalacom
Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy
| Study group | Role | What they receive |
|---|---|---|
| Travoprost/Timolol therapy | Active comparator | Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy Receives: Drug: Travoprost/timolol therapy; Drug: Latanoprost/Timolol therapy |
| Latanoprost/Timolol therapy | Active comparator | Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. 24-hour pressure monitoring will be carried out for this drug after 3 months of chronic dosing. All patients will be crossed over to therapy for 3 months with latanoprost/timolol fixed combination drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy Receives: Drug: Travoprost/timolol therapy; Drug: Latanoprost/Timolol therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hour intraocular pressure reduction between the two medications
Evaluation of 24-hour pressure every 4 hours at habitual position with calibrated Goldmann technology tonometer
Measured: 3 months
Secondary outcomes (2)
rate of adverse events with the two medications
At each visit local and systemic adverse effects that occurred during the treatment period will be recorded. Adverse events are evaluated by asking patients a general query about their state of health.
Measured: 3 months
ocular surface indicators after 3 months of therapy with the two medications
Selected indicators (break up time of tears, Schirmer test and degree of corneal stain after application of fluorescein) will be employed after 3 months of therapy to determine the health status of ocular surface with the two medications.
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 posted30 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionJan 2013
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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AGP Konstas, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779284
- Sponsor's protocol ID
- A23
- Status last verified
- May 2014
- First submitted
- 25 Jan 2013
- 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
- 24-Hour Efficacy of Travoprost/Timolol Benzalkonium Chloride BAK Free Compared With Latanoprost/Timolol Fixed Combination Therapy in Subjects With Open-Angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy
- ClinicalTrials.gov ID
- NCT01779284
- Acronym / sponsor ID
- A23
- Conditions
- Glaucoma
- Keywords
- glaucoma, fixed combinations, 24-hour monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Jan 2013 (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.
The primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium chloride given once in the evening, versus the latanoprost/timolol fixed combination given in the evening. It is assumed that travoprost/timolol fixed combination will provide better quality of 24-hour pressure control.
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 therapy, Drug: Latanoprost/Timolol therapyEnrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy |
| Latanoprost/Timolol therapy | Active comparator | Drug: Travoprost/timolol therapy, Drug: Latanoprost/Timolol therapyEnrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. 24-hour pressure monitoring will be carried out for this drug after 3 months of chronic dosing. All patients will be crossed over to therapy for 3 months with latanoprost/timolol fixed combination drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy |
Who may qualify
- Ages
- 29 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Primary open-angle glaucoma or exfoliative glaucoma
- Patients who require additional IOP lowering on latanoprost monotherapy
- Morning IOP greater than 20 mm Hg on latanoprost monotherapy
- Untreated morning IOP greater than 26 mm Hg
- Patients older than 29 years
Key exclusion criteria (11 listed)
- History of combined topical therapy
- Contraindication to prostaglandins or timolol
- History of ocular trauma or inflammation; intraocular surgery; severe dry eyes; use of contact lenses
- Sign of ocular infection except for mild blepharitis
- Any corneal abnormality that could have affected the measurement of IOP
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 therapyAlso: DuoTrav BAK FreeEvaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing | Drug | Latanoprost/Timolol therapy, Travoprost/Timolol therapy |
| Latanoprost/Timolol therapyAlso: XalacomEvaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy | Drug | Latanoprost/Timolol therapy, Travoprost/Timolol therapy |
Primary outcome
Mean 24-hour intraocular pressure reduction between the two medications
Time frame: 3 months
Evaluation of 24-hour pressure every 4 hours at habitual position with calibrated Goldmann technology tonometer
2 secondary outcomes
rate of adverse events with the two medications
Time frame: 3 months
ocular surface indicators after 3 months of therapy with the two medications
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.
The record lists no contact. Use the official record to reach the sponsor.
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 therapy and Latanoprost/Timolol therapy 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 13 inclusion and 11 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 intraocular pressure reduction between the two medications (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.