GlaucomaPhase 4NCT00757835
24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG
A Phase 4 study testing treatment with latanoprost/timolol fixed combination and latanoprost/timolol fixed combination drops in people with Glaucoma, run by Aristotle University Of Thessaloniki.
Trial summary
A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- treatment with latanoprost/timolol fixed combination and latanoprost/timolol fixed combination drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Mar 2009
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has XFG and is older than 29 years
- The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)
- Patient can be safely washed out without risk for significant deterioration
- Distance best corrected Snelen visual acuity better than 0.1
- No contraindication to prostaglandins or β-blockers
- No history of lack of response (<10% reduction) to any medication
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- Patient can understand the instructions and comply to medications
- Open normal appearing angles
- No sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc
Who cannot join
- History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- Patient is a female of childbearing potential or lactating mother
About this study
Official title: 24-hour IOP Control With the Travoprost/Timolol Fixed Combination Compared With the Latanoprost/Timolol Fixed Combination, When Both Are Dosed in the Evening in Patients With Exfoliative Glaucoma
A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.
- Conditions
- Glaucoma
- Being tested
- treatment with latanoprost/timolol fixed combination, latanoprost/timolol fixed combination drops
- Keywords
- 24-hour IOP, exfoliative glaucoma, travoprost/timolol, latanoprost/timolol, fixed combinations
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment with latanoprost/timolol fixed combinationDrug
dosing in the evening with the two fixed combinations
latanoprost/timolol fixed combination dropsDrug
once in the evening
| Study group | Role | What they receive |
|---|---|---|
| Travoprost/timolol therapy | Active comparator | treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring. Receives: Drug: treatment with latanoprost/timolol fixed combination; Drug: latanoprost/timolol fixed combination drops |
| Latanoprost/timolol therapy | Active comparator | Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring. Receives: Drug: treatment with latanoprost/timolol fixed combination; Drug: latanoprost/timolol fixed combination drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol
Measured: 3 months
Secondary outcomes (1)
Incidence of side effects 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 posted23 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionMar 2009
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
- 40 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 G Konstas, MD, PhD, Principal investigator, Glaucoma Unit, 1st University Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757835
- Sponsor's protocol ID
- A6219
- Status last verified
- Dec 2020
- First submitted
- 19 Sep 2008
- 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
- 24-hour IOP Control With the Travoprost/Timolol Fixed Combination Compared With the Latanoprost/Timolol Fixed Combination, When Both Are Dosed in the Evening in Patients With Exfoliative Glaucoma
- ClinicalTrials.gov ID
- NCT00757835
- Acronym / sponsor ID
- A6219
- Conditions
- Glaucoma
- Keywords
- 24-hour IOP, exfoliative glaucoma, travoprost/timolol, latanoprost/timolol, fixed combinations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- May 2008 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 Sep 2008 (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 crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.
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: treatment with latanoprost/timolol fixed combination, Drug: latanoprost/timolol fixed combination dropstreatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring. |
| Latanoprost/timolol therapy | Active comparator | Drug: treatment with latanoprost/timolol fixed combination, Drug: latanoprost/timolol fixed combination dropsTreatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient has XFG and is older than 29 years
- The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)
- Patient can be safely washed out without risk for significant deterioration
- Distance best corrected Snelen visual acuity better than 0.1
- No contraindication to prostaglandins or β-blockers
Key exclusion criteria (2 listed)
- History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treatment with latanoprost/timolol fixed combinationdosing in the evening with the two fixed combinations | Drug | Latanoprost/timolol therapy, Travoprost/timolol therapy |
| latanoprost/timolol fixed combination dropsonce in the evening | Drug | Latanoprost/timolol therapy, Travoprost/timolol therapy |
Primary outcome
Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol
Time frame: 3 months
1 secondary outcome
Incidence of side effects 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 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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing treatment with latanoprost/timolol fixed combination and latanoprost/timolol fixed combination drops in people with Glaucoma, run by Aristotle University Of Thessaloniki.
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 9 inclusion and 2 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.
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?
Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol (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 17 Dec 2020.