GlaucomaPhase 3NCT01433900
Switching From Preserved to Preserved-free Treatments for Glaucoma.
A Phase 3 study testing Tafluprost and Latanoprost in people with Glaucoma, run by Paolo Fogagnolo at 1 site in Italy.
Trial summary
A 1-year prospective, randomized, investigator-masked trial comparing the confocal and clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost) in newly-diagnosed glaucoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Tafluprost and Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- May 2012to Jun 2014
- Phase
- Phase 3
- 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
- The patient is suffering from ocular hypertension, POAG, PEX, NTG. Glaucoma definition is based on the European Glaucoma Society Guidelines.
- The patient is newly-diagnosed
- No fluorescein staining at baseline and no observable signs of ocular surface disease
- No treatment with topical BAK-containing products for at least 6 months
- Treatment of naïve patients
Who cannot join
- Unwilling to sign informed consent
- Not at least 18 years old
- Ocular condition that are of safety concern and that can interfere with the study results
- Closed/barely open anterior chamber angles or history of acute angle closure.
- Ocular surgery or argon laser trabeculoplasty within the last year. Ocular inflammation/infection occurring within three months prior to pre-trial visit.
- Presence of the following ocular conditions: KCS, moderate-severe blepharitis, Rosacea, Sjogren syndrome, pterygium, contact lens users.
Show all 15Show fewer
- Use of concomitant topical ocular medication that can interfere with study medication
- Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
- Any corneal pathology
- Diabetes at any stage
- Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement.
- Refractive surgery patients
- Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing.
- Inability to adhere to treatment/visit plan.
- Have participated in any other clinical trial (i.e., requiring informed consent) within one to three month prior to pre-trial visit (depending on ethics committee decisions).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Paolo Hospital
Milan, 20142
Luca Rossetti, MD
Paolo Fogagnolo, MD
About this study
Official title: The Advantage of Switching From Preserved to Preserved-free Treatments in Glaucoma. A Clinical and Confocal Study.
A 1-year prospective, randomized, investigator-masked trial comparing the confocal and clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.
Read the detailed description
The study protocol comprises 5 visits: baseline, month 3, month 6, month 9, month 12.
At baseline a clinical evaluator will perform a complete ophthalmologic evaluation to confirm diagnosis. The following examinations will be done in the following sequence: anterior segment examination, Shirmer test, Break-up time test. Thereafter, a confocal evaluator will perform confocal microscopy of the central and the peripheral cornea. Finally, contact measurements will be done in the following order: IOP (which will be measured at 3 pm), pachimetry (only at baseline visit) and gonioscony (only at baseline visit). A 15 minutes interval will elapse between two consecutive tests.
- Conditions
- Glaucoma
- Being tested
- Tafluprost, Latanoprost
- Keywords
- glaucoma, intraocular pressure, ocular surface, benzalkonium chloride
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafluprostDrug
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
LatanoprostDrug
1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
| Study group | Role | What they receive |
|---|---|---|
| Tafluprost | Active comparator | 1 drop of tafluprost to eligible eye(s) once daily (at 9 pm) Receives: Drug: Tafluprost |
| Latanoprost | Active comparator | 1 drop of latanoprost to eligible eye(s) once daily (at 9 pm) Receives: Drug: Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants
Measured: Month 3, 6, 9, 12
Secondary outcomes (3)
Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity)
Measured: Months 3, 6, 9 ,12
Changes in density of epithelial cells, Langerhans cells, endothelial cells
Measured: Month 3, 6, 9 ,12
Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test)
Measured: Month 3, 6, 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionJun 2014 (estimated)
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 GlaucomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paolo Fogagnolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paolo Fogagnolo, University of Milan
- Investigators
- Luca Rossetti, MD, Principal investigator, San Paolo Hospital, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433900
- Sponsor's protocol ID
- MSD-007
- Status last verified
- Sep 2011
- First submitted
- 25 Jul 2011
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fogagnolo P, Dipinto A, Vanzulli E, Maggiolo E, De Cilla' S, Autelitano A, Rossetti L. A 1-year randomized study of the clinical and confocal effects of tafluprost and latanoprost in newly diagnosed glaucoma patients. Adv Ther. 2015 Apr;32(4):356-69. doi: 10.1007/s12325-015-0205-5. Epub 2015 Apr 19.
PubMed 25893514
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Advantage of Switching From Preserved to Preserved-free Treatments in Glaucoma. A Clinical and Confocal Study.
- ClinicalTrials.gov ID
- NCT01433900
- Acronym / sponsor ID
- MSD-007
- Conditions
- Glaucoma
- Keywords
- glaucoma, intraocular pressure, ocular surface, benzalkonium chloride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Paolo FogagnoloUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2014 (estimated)
- First posted
- 14 Sep 2011 (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 1-year prospective, randomized, investigator-masked trial comparing the confocal and clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.
Detailed description
The study protocol comprises 5 visits: baseline, month 3, month 6, month 9, month 12.
At baseline a clinical evaluator will perform a complete ophthalmologic evaluation to confirm diagnosis. The following examinations will be done in the following sequence: anterior segment examination, Shirmer test, Break-up time test. Thereafter, a confocal evaluator will perform confocal microscopy of the central and the peripheral cornea. Finally, contact measurements will be done in the following order: IOP (which will be measured at 3 pm), pachimetry (only at baseline visit) and gonioscony (only at baseline visit). A 15 minutes interval will elapse between two consecutive tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tafluprost | Active comparator | Drug: Tafluprost1 drop of tafluprost to eligible eye(s) once daily (at 9 pm) |
| Latanoprost | Active comparator | Drug: Latanoprost1 drop of latanoprost to eligible eye(s) once daily (at 9 pm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is suffering from ocular hypertension, POAG, PEX, NTG. Glaucoma definition is based on the European Glaucoma Society Guidelines.
- The patient is newly-diagnosed
- No fluorescein staining at baseline and no observable signs of ocular surface disease
- No treatment with topical BAK-containing products for at least 6 months
- Treatment of naïve patients
Key exclusion criteria (15 listed)
- Unwilling to sign informed consent
- Not at least 18 years old
- Ocular condition that are of safety concern and that can interfere with the study results
- Closed/barely open anterior chamber angles or history of acute angle closure.
- Ocular surgery or argon laser trabeculoplasty within the last year. Ocular inflammation/infection occurring within three months prior to pre-trial visit.
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 |
|---|---|---|
| Tafluprost1 drop of tafluprost to eligible eye(s) once daily (at 9 pm) | Drug | Tafluprost |
| Latanoprost1 drop of tafluprost to eligible eye(s) once daily (at 9 pm) | Drug | Latanoprost |
Primary outcome
Changes in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants
Time frame: Month 3, 6, 9, 12
3 secondary outcomes
Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity)
Time frame: Months 3, 6, 9 ,12
Changes in density of epithelial cells, Langerhans cells, endothelial cells
Time frame: Month 3, 6, 9 ,12
Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test)
Time frame: Month 3, 6, 9, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Derived from this study: PubMed 25893514Fogagnolo P, Dipinto A, Vanzulli E, Maggiolo E, De Cilla' S, Autelitano A, Rossetti L. A 1-year randomized study of the clinical and confocal effects of tafluprost and latanoprost in newly diagnosed glaucoma patients. Adv Ther. 2015 Apr;32(4):356-69. doi: 10.1007/s12325-015-0205-5. Epub 2015 Apr 19.
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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.
Luca Rossetti, MD principal investigator
San Paolo Hospital, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tafluprost and Latanoprost in people with Glaucoma, run by Paolo Fogagnolo at 1 site 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 5 inclusion and 15 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 16 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Luca Rossetti, MD (+390281844401, luca.rossetti@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants (time frame: Month 3, 6, 9, 12). 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 NCT01433900, 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 16 May 2014.