Glaucoma, Open-AnglePhase 4HERONCT05299593
24-hour Efficacy and Tolerability of the Tafluprost-timolol Fixed Association Without Preservatives in Glaucomatous or Ocular Hypertensive Patients Already Treated With Latanoprost Preserved With BAK. A Prospective, Open Study of 3 Months Duration.
A Phase 4 study testing tafluprost/timolol in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Fondazione G.B. Bietti, IRCCS at 3 sites in Italy.
Trial summary
This is a phase IV, interventional, multi-center, open clinical Trial. Patients will be administered one eye drop of tafluprost/timolol fixed combination at 20:00 (+/- 1 hour), in the treatment of open angle glaucoma and ocular hypertension. The patients will suspend the treatment with latanoprost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- tafluprost/timolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesItaly
- Study dates
- 4 Jun 2020to 30 Jun 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ocular hypertension or primary open-angle glaucoma or secondary to dispersion of pigment or pseudoesfoliatio;
- IOP <22 mmHg in latanoprost therapy in both eyes since at least 6 weeks and > 17 mmHg in at least one eye;
- OSD at least mild as defined by DEQ-5 (score> 6);
- Examination of the visual field during the three months prior to enrollment (if not present, the patient must be subjected to a visual field at the screening visit);
- Treatment with latanoprost BAK-preserved from at least 6 weeks;
- Subject agrees to follow the study procedures and signs the EC-approved ICF;
- For women of child-bearing potential, blood screening for beta-HCG before randomization and use of one effective method of birth control during the conduct of the study
Who cannot join
- Inability to understand and sign informed consent;
- Age under 18 years;
- Other forms of secondary glaucoma (besides pigmentary and pseudoesfoliatius);
- Narrow angle or history of acute glaucoma attacks;
- Previous history of trabeculoplasty in the previous 6 months;
- History of glaucoma surgery or refractive surgery;
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- Cataract surgery in the 6 months prior to enrollment;
- Contraindications to the use of beta-blockers (reactive airway disease, including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease; sinus bradycardia, sick sinus syndrome, including sinoatrial block, second or third degree atrioventricular block not controlled by pacemaker; full-blown heart failure, cardiogenic shock);
- Damage to the visual field with a mean deviation (MD) <-20 dB;
- BCVA <2/10;
- Topical ocular drugs performed within 3 months prior to enrollment that may interfere with the study results (eg steroids, non-steroidal anti-inflammatory drugs, immunosuppressants, etc.);
- Use of tear substitutes containing preservatives within 30 days prior to enrollment;
- Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study or would impair interpretation of results;
- Corneal anomalies that preclude an accurate measurement of IOP (eg astigmatism> 3 D, keratoconus, opacity or corneal ulcers);
- Any type of previous corneal or conjunctival surgery including pterygium removal or refractive surgery;
- Unstable systemic disorders that may require the initiation or variation of therapies that may influence intraocular pressure during the study;
- Woman of childbearing potential, or who is currently pregnant or breastfeeding;
- Inability to adhere to the procedures required by the protocol or to the studio treatment;
- Participation in another experimental therapeutic protocol within one month prior to baseline and during the study period (participation in natural history study is allowed);
- Hypersensitivity to the active substances or to any of the excipients.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
ASST Santi Paolo e Carlo
Milan, 20142
Alfonso Strianese, MD, 3347302078 ext. 0039, alfonsostrianese95@gmail.com
- Not yet recruiting
Università di Pavia Policlinico S. Matteo
Pavia, 27100
Ivano Riva, MD, 3471630745 ext. 0039, ivano.riva@virgilio.it
- Recruiting
IRCCS G.B.Bietti Foundation for the study and Research in Ophthalmology ONLUS
Roma, 00198
Lucia Tanga, MD, 3381177456 ext. 0039, lucia.tanga@fondazionebietti.it
About this study
This is a phase IV, interventional, multi-center, open clinical Trial. Patients will be administered one eye drop of tafluprost/timolol fixed combination at 20:00 (+/- 1 hour), in the treatment of open angle glaucoma and ocular hypertension. The patients will suspend the treatment with latanoprost.
Read the detailed description
This is a phase IV, interventional, multi-center, not comparative, open clinical Trial to evaluate the effectiveness in reducing the mean 24-hour IOP of the preservative-free fixed combination of Tafluprost 0.0015% and Timolol 0.5% administered once at night (8pm) in POAG or OHT patients suffering from mild OSD and requiring further IOP reduction while in topical treatment with BAK-preserved Latanoprost 0.05 mg/ml. Three Italian recruiting centers are included in the study and the estimated number of patients to be enrolled is 43. After evaluating the patient's eligibility, the patients will suspend the treatment with latanoprost and will be administered one eye drop of tafluprost/timolol fixed combination at 20:00 (+/- 1 hour) at the end of the V1B visit. Active drug will be contained (about 30 µl, one drop) contains about 0.45 micrograms of tafluprost and 0.15 mg of timolol.
The Study consists in 6 Visits:
- Screening visit V0 and baseline V1A.
- Treatment period visit V1B; V2; V3A; V3B.
- End of study V3B.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- tafluprost/timolol
- Keywords
- Glaucoma, ocular hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tafluprost/timololDrug
One ml active drug contains: 15 micrograms of tafluprost and 5 mg of timolol (as maleate).
A single-dose container (0.3 ml) of eye drops, solution, contains 4.5 micrograms of tafluprost and 1.5 mg of timolol. One drop (about 30 µl) contains about 0.45 micrograms of tafluprost and 0.15 mg of timolol. Patients will be administrered with one drop in the conjunctival sac of the affected eye (s) once a day.
| Study group | Role | What they receive |
|---|---|---|
| tafluprost/timolol | Experimental | Enrolled patients will be treated with one drop of the fixed combination Tafluprost-Thymol without preservative in the evening at 20.00 (+/- 1 hour). Patients will be administrered with one drop in the conjunctival sac of the affected eye (s) once a day. Receives: Drug: tafluprost/timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of the mean 24-h absolute Intraocular Pressure (IOP)
Reduction measured in mmHg (millimeters of mercury).
Measured: through study completion, an average of 3 months
Secondary outcomes (9)
Evaluation of the average reduction of Intraocular Pressure(IOP) at 24-hour
Curve measured in mmHg.
Measured: through study completion, an average of 3 months
Evaluation of the percentage reduction of the average Intraocular Pressure(IOP) of the 24 hours
percentage at each time point.
Measured: through study completion, an average of 3 months
Evaluation of the average daytime reduction and night of the Intraocular Pressure(IOP)
Measured in mmHg
Measured: through study completion, an average of 3 months
Evaluation of the percentage of patients achieving Intraocular Pressure(IOP) reduction in average
reductions in average IOP at 24h when plus 20%, when plus 25%,when plus 30%.
Measured: through study completion, an average of 3 months
Evaluation of the changes in the Corneale Staining Test (CFS) and Break-up Time Test (tBUT) parameters
with fluorescein, measured area and density
Measured: through study completion, an average of 3 months
Evaluation of the changes in Dry Eye Questionnaire (DEQ-5)
DEQ-5 questionnaire Score
Measured: through study completion, an average of 3 months
Evaluation of the changes of the number, activation of corneal, conjunctival dendritic cells to confocal microscopy.
Changes number corneal and dendritic cells
Measured: through study completion, an average of 3 months
Evaluation of the changes of the number of conjunctival goblet cells to confocal microscopy
Changes of number of goblet cells
Measured: through study completion, an average of 3 months
Evaluation of the changes in quality of life
NEIVFQ-25 questionnaire (score).
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start4 Jun 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, open label
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione G.B. Bietti, IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Oddone, MD, Principal investigator, IRCCS G.B.Bietti Foundation for the study and Research in Ophthalmology ONLUSLuciano Quaranta, MD, Principal investigator, Università di Pavia Policlinico S. MatteoLuca Rossetti, MD, Principal investigator, ASST Santi Paolo e Carlo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299593
- Sponsor's protocol ID
- HERO
- Acronym
- HERO
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a Plan to make available to other researches.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24-hour Efficacy and Tolerability of the Tafluprost-timolol Fixed Association Without Preservatives in Glaucomatous or Ocular Hypertensive Patients Already Treated With Latanoprost Preserved With BAK. A Prospective, Open Study of 3 Months Duration.
- ClinicalTrials.gov ID
- NCT05299593
- Acronym / sponsor ID
- HERO / HERO
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- Glaucoma, ocular hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fondazione G.B. Bietti, IRCCSUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 29 Mar 2022 (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.
This is a phase IV, interventional, multi-center, open clinical Trial. Patients will be administered one eye drop of tafluprost/timolol fixed combination at 20:00 (+/- 1 hour), in the treatment of open angle glaucoma and ocular hypertension. The patients will suspend the treatment with latanoprost.
Detailed description
This is a phase IV, interventional, multi-center, not comparative, open clinical Trial to evaluate the effectiveness in reducing the mean 24-hour IOP of the preservative-free fixed combination of Tafluprost 0.0015% and Timolol 0.5% administered once at night (8pm) in POAG or OHT patients suffering from mild OSD and requiring further IOP reduction while in topical treatment with BAK-preserved Latanoprost 0.05 mg/ml. Three Italian recruiting centers are included in the study and the estimated number of patients to be enrolled is 43. After evaluating the patient's eligibility, the patients will suspend the treatment with latanoprost and will be administered one eye drop of tafluprost/timolol fixed combination at 20:00 (+/- 1 hour) at the end of the V1B visit. Active drug will be contained (about 30 µl, one drop) contains about 0.45 micrograms of tafluprost and 0.15 mg of timolol.
The Study consists in 6 Visits:
- Screening visit V0 and baseline V1A.
- Treatment period visit V1B; V2; V3A; V3B.
- End of study V3B.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, open label
| Arm | Type | Receives |
|---|---|---|
| tafluprost/timolol | Experimental | Drug: tafluprost/timololEnrolled patients will be treated with one drop of the fixed combination Tafluprost-Thymol without preservative in the evening at 20.00 (+/- 1 hour). Patients will be administrered with one drop in the conjunctival sac of the affected eye (s) once a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ocular hypertension or primary open-angle glaucoma or secondary to dispersion of pigment or pseudoesfoliatio;
- IOP <22 mmHg in latanoprost therapy in both eyes since at least 6 weeks and > 17 mmHg in at least one eye;
- OSD at least mild as defined by DEQ-5 (score> 6);
- Examination of the visual field during the three months prior to enrollment (if not present, the patient must be subjected to a visual field at the screening visit);
- Treatment with latanoprost BAK-preserved from at least 6 weeks;
Key exclusion criteria (20 listed)
- Inability to understand and sign informed consent;
- Age under 18 years;
- Other forms of secondary glaucoma (besides pigmentary and pseudoesfoliatius);
- Narrow angle or history of acute glaucoma attacks;
- Previous history of trabeculoplasty in the previous 6 months;
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/timololOne ml active drug contains: 15 micrograms of tafluprost and 5 mg of timolol (as maleate). A single-dose container (0.3 ml) of eye drops, solution, contains 4.5 micrograms of tafluprost and 1.5 mg of timolol. One drop (about 30 µl) contains about 0.45 micrograms of tafluprost and 0.15 mg of timolol. Patients will be administrered with one drop in the conjunctival sac of the affected eye (s) once a day. | Drug | tafluprost/timolol |
Primary outcome
The evaluation of the mean 24-h absolute Intraocular Pressure (IOP)
Time frame: through study completion, an average of 3 months
Reduction measured in mmHg (millimeters of mercury).
9 secondary outcomes
Evaluation of the average reduction of Intraocular Pressure(IOP) at 24-hour
Time frame: through study completion, an average of 3 months
Evaluation of the percentage reduction of the average Intraocular Pressure(IOP) of the 24 hours
Time frame: through study completion, an average of 3 months
Evaluation of the average daytime reduction and night of the Intraocular Pressure(IOP)
Time frame: through study completion, an average of 3 months
Evaluation of the percentage of patients achieving Intraocular Pressure(IOP) reduction in average
Time frame: through study completion, an average of 3 months
Evaluation of the changes in the Corneale Staining Test (CFS) and Break-up Time Test (tBUT) parameters
Time frame: through study completion, an average of 3 months
Evaluation of the changes in Dry Eye Questionnaire (DEQ-5)
Time frame: through study completion, an average of 3 months
Evaluation of the changes of the number, activation of corneal, conjunctival dendritic cells to confocal microscopy.
Time frame: through study completion, an average of 3 months
Evaluation of the changes of the number of conjunctival goblet cells to confocal microscopy
Time frame: through study completion, an average of 3 months
Evaluation of the changes in quality of life
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No. There is not a Plan to make available to other researches.
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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.
Francesco Oddone, MD principal investigator
IRCCS G.B.Bietti Foundation for the study and Research in Ophthalmology ONLUS
Luciano Quaranta, MD principal investigator
Università di Pavia Policlinico S. Matteo
Luca Rossetti, MD principal investigator
ASST Santi Paolo e Carlo
3 sites 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 in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Fondazione G.B. Bietti, IRCCS at 3 sites in Italy.
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 20 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Oddone, MD (0685356727 ext. 0039, francesco.oddone@fondazionebietti.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evaluation of the mean 24-h absolute Intraocular Pressure (IOP) (time frame: through study completion, an average of 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 29 Mar 2022.