Glaucoma, Open-AnglePhase 4TTFCNCT03612817
Preservative-free Tafluprost/Timolol Fixed Combination: Morning vs Evening Dosing
A Phase 4 study testing Tafluprost/timolol fixed combination in people with Glaucoma, Open-Angle, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The ideal dosing for preservative-free tafluprost/timolol fixed combination remains to be elucidated. The present study compared the 24-hour intraocular pressure efficacy obtained with tafluprost/timolol given once in the evening with placebo once in the morning, versus that with the same fixed combination… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Tafluprost/timolol fixed combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2017to Jul 2018
- 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
- age between 21-85 years;
- mild to moderate glaucomatous disc damage and visual field loss (less than -12 dB mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio);
- visual acuity greater than 0.1 in the study eye;
- open anterior chamber angles;
- in each patient the diagnosis of open-angle glaucoma will be made by the principal investigator based on the European Glaucoma Society criteria;
- study patients will have to demonstrate a reliable visual field (at least two visual fields with less than 20% fixation losses, false positives, or negatives);
- patient should understand the study instructions and to be willing to attend all follow-up appointments and should be willing to comply with study medication usage.
Who cannot join
- previous history of less than 10% IOP decrease on any IOP-lowering medication;
- evidence of concurrent conjunctivitis, keratitis, or uveitis in either eye;
- history of inadequate adherence; intolerance, or contraindication to either prostaglandins, β-blockers, dorzolamide, or benzalconium chloride (BAK);
- severe ocular surface disease, intraocular conventional or laser surgery in the study eye (within 6 months prior to enrolment);
- previous history of ocular trauma;
- use of corticosteroids (within 3 months before the enrolment) and use of contact lenses;
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- patients will also be excluded if on baseline exam they show clinical evidence of inflammation, signs of ocular infection (except blepharitis), signs of any corneal abnormality that will affect subsequent IOP measurements;
- unwillingness to participate in the trial;
- females of childbearing potential or lactating mothers.
Trial locations and contacts
1 site in 1 country.
Greece1 site
1st University Department of Ophthalmology
Thessaloniki, Makedonia, 54636
About this study
Official title: A 3-month Study Investigating the 24-hour Efficacy With the Preservative-free Tafluprost/Timolol Fixed Combination Dosed Morning, or Evening in Subjects With Open-angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy
The ideal dosing for preservative-free tafluprost/timolol fixed combination remains to be elucidated. The present study compared the 24-hour intraocular pressure efficacy obtained with tafluprost/timolol given once in the evening with placebo once in the morning, versus that with the same fixed combination administered once in the morning with placebo given once in the evening in consecutive patients with open-angle glaucoma insufficiently controlled with branded, or generic latanoprost monotherapy.
Read the detailed description
Prospective, observer-masked, placebo-controlled, crossover, comparison in consecutive open-angle glaucoma patients, insufficiently controlled with preserved latanoprost monotherapy (mean 24-hr IOP greater than 20 mmHg). Patients were randomized to either morning (08:00), or evening (20:00) preservative-free tafluprost/timolol fixed combination for 3 months and then were crossed over. After each treatment period patients underwent habitual 24-hour intraocular pressure monitoring with Goldmann tonometry in the sitting position (at 10:00, 14:00, 18:00 and 22:00) and Perkins tonometry in the supine position (at 02:00 and 06:00).
Primary Study Objective: Mean 24-hour efficacy with both dosing regimens of tafluprost/timolol fixed combination versus latanoprost monotherapy.
Secondary Study Objectives
- Mean efficacy with the evening dosing of tafluprost/timolol compared with the morning-dosed tafluprost/timolol fixed combination at each time point measured.
- Mean daytime and mean nighttime IOP control with the two dosing regimens.
- Mean peak and fluctuation of 24-hour pressure with the evening and the morning dosing of the fixed combination.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Tafluprost/timolol fixed combination
- Keywords
- tafluprost/timolol fixed combination, 24-hour IOP control
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tafluprost/timolol fixed combinationDrug
Also called Taptiqom
Evaluation of 24-hour pressure control with tafluprost/timolol given in the evening or morning
| Study group | Role | What they receive |
|---|---|---|
| Tafluprost/timolol with PM dosing | Active comparator | Therapy with Tafluprost/timolol fixed combination drops dosed PM (20:00) Receives: Drug: Tafluprost/timolol fixed combination |
| Tafluprost/timolol with AM dosing | Active comparator | Therapy with Tafluprost/timolol fixed combination drops dosed AM (08:00) Receives: Drug: Tafluprost/timolol fixed combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hour pressure control with Tafluprost/timolol fixed combination dosed morning or evening
24-hour efficacy documented after each period of therapy
Measured: 3-month study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study startJan 2017
- Primary completionApr 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies 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
- Model description
- Patients first undergo a baseline, habitual 24-hour pressure assessment with branded, or generic latanoprost. Suitably qualified open-angle glaucoma patients (latanoprost-treated, mean 24-hour pressure greater than 20 mm Hg) are randomized for Period 1 to receive either tafluprost/timolol fixed combination drops once in the evening (20:00) and placebo drops in the morning (08:00), or tafluporst/timolol drops once in the morning (08:00) and placebo in the evening (20:00). After 3 months of chronic therapy (± 2 weeks) study patients undergo a treated, habitual 24-hour pressure assessment. Study subjects are then switched to the opposite treatment regimen for Period 2 (tafluprost/timolol in the evening instead of morning etc) and after another 3 months they undergo the third and final evaluation of their 24-hour pressure.
- 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
- Collaborators
- Santen Oy
- Responsible party
- Principal investigator, AGP Konstas, Aristotle University Of Thessaloniki
- Investigators
- Theodoros Giannopoulos, MD, Study director, Aristotle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612817
- Sponsor's protocol ID
- 433
- Acronym
- TTFC
- Status last verified
- Dec 2020
- First submitted
- 20 Jul 2018
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Konstas AG, Katsanos A, Athanasopoulos GP, Voudouragkaki IC, Panagiotou ES, Pagkalidou E, Haidich AB, Giannoulis DA, Spathi E, Giannopoulos T, Katz LJ. Preservative-free tafluprost/timolol fixed combination: comparative 24-h efficacy administered morning or evening in open-angle glaucoma patients. Expert Opin Pharmacother. 2018 Dec;19(18):1981-1988. doi: 10.1080/14656566.2018.1534958. Epub 2018 Oct 17.
PubMed 30328725
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 Study Investigating the 24-hour Efficacy With the Preservative-free Tafluprost/Timolol Fixed Combination Dosed Morning, or Evening in Subjects With Open-angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy
- ClinicalTrials.gov ID
- NCT03612817
- Acronym / sponsor ID
- TTFC / 433
- Conditions
- Glaucoma, Open-Angle
- Keywords
- tafluprost/timolol fixed combination, 24-hour IOP control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Santen Oy
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- 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 ideal dosing for preservative-free tafluprost/timolol fixed combination remains to be elucidated. The present study compared the 24-hour intraocular pressure efficacy obtained with tafluprost/timolol given once in the evening with placebo once in the morning, versus that with the same fixed combination administered once in the morning with placebo given once in the evening in consecutive patients with open-angle glaucoma insufficiently controlled with branded, or generic latanoprost monotherapy.
Detailed description
Prospective, observer-masked, placebo-controlled, crossover, comparison in consecutive open-angle glaucoma patients, insufficiently controlled with preserved latanoprost monotherapy (mean 24-hr IOP greater than 20 mmHg). Patients were randomized to either morning (08:00), or evening (20:00) preservative-free tafluprost/timolol fixed combination for 3 months and then were crossed over. After each treatment period patients underwent habitual 24-hour intraocular pressure monitoring with Goldmann tonometry in the sitting position (at 10:00, 14:00, 18:00 and 22:00) and Perkins tonometry in the supine position (at 02:00 and 06:00).
Primary Study Objective: Mean 24-hour efficacy with both dosing regimens of tafluprost/timolol fixed combination versus latanoprost monotherapy.
Secondary Study Objectives
- Mean efficacy with the evening dosing of tafluprost/timolol compared with the morning-dosed tafluprost/timolol fixed combination at each time point measured.
- Mean daytime and mean nighttime IOP control with the two dosing regimens.
- Mean peak and fluctuation of 24-hour pressure with the evening and the morning dosing of the fixed combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients first undergo a baseline, habitual 24-hour pressure assessment with branded, or generic latanoprost. Suitably qualified open-angle glaucoma patients (latanoprost-treated, mean 24-hour pressure greater than 20 mm Hg) are randomized for Period 1 to receive either tafluprost/timolol fixed combination drops once in the evening (20:00) and placebo drops in the morning (08:00), or tafluporst/timolol drops once in the morning (08:00) and placebo in the evening (20:00). After 3 months of chronic therapy (± 2 weeks) study patients undergo a treated, habitual 24-hour pressure assessment. Study subjects are then switched to the opposite treatment regimen for Period 2 (tafluprost/timolol in the evening instead of morning etc) and after another 3 months they undergo the third and final evaluation of their 24-hour pressure.
| Arm | Type | Receives |
|---|---|---|
| Tafluprost/timolol with PM dosing | Active comparator | Drug: Tafluprost/timolol fixed combinationTherapy with Tafluprost/timolol fixed combination drops dosed PM (20:00) |
| Tafluprost/timolol with AM dosing | Active comparator | Drug: Tafluprost/timolol fixed combinationTherapy with Tafluprost/timolol fixed combination drops dosed AM (08:00) |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age between 21-85 years;
- mild to moderate glaucomatous disc damage and visual field loss (less than -12 dB mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio);
- visual acuity greater than 0.1 in the study eye;
- open anterior chamber angles;
- in each patient the diagnosis of open-angle glaucoma will be made by the principal investigator based on the European Glaucoma Society criteria;
Key exclusion criteria (9 listed)
- previous history of less than 10% IOP decrease on any IOP-lowering medication;
- evidence of concurrent conjunctivitis, keratitis, or uveitis in either eye;
- history of inadequate adherence; intolerance, or contraindication to either prostaglandins, β-blockers, dorzolamide, or benzalconium chloride (BAK);
- severe ocular surface disease, intraocular conventional or laser surgery in the study eye (within 6 months prior to enrolment);
- previous history of ocular trauma;
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 |
|---|---|---|
| Tafluprost/timolol fixed combinationAlso: TaptiqomEvaluation of 24-hour pressure control with tafluprost/timolol given in the evening or morning | Drug | Tafluprost/timolol with AM dosing, Tafluprost/timolol with PM dosing |
Primary outcome
Mean 24-hour pressure control with Tafluprost/timolol fixed combination dosed morning or evening
Time frame: 3-month study
24-hour efficacy documented after each period of therapy
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.
- Derived from this study: PubMed 30328725Konstas AG, Katsanos A, Athanasopoulos GP, Voudouragkaki IC, Panagiotou ES, Pagkalidou E, Haidich AB, Giannoulis DA, Spathi E, Giannopoulos T, Katz LJ. Preservative-free tafluprost/timolol fixed combination: comparative 24-h efficacy administered morning or evening in open-angle glaucoma patients. Expert Opin Pharmacother. 2018 Dec;19(18):1981-1988. doi: 10.1080/14656566.2018.1534958. Epub 2018 Oct 17.
- Individual participant dataSharing planned: No
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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.
Theodoros Giannopoulos, MD study director
Aristotle University
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 Tafluprost/timolol fixed combination in people with Glaucoma, Open-Angle, 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 9 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.
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 pressure control with Tafluprost/timolol fixed combination dosed morning or evening (time frame: 3-month study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03612817, which also lists 1 linked publication.
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.