Primary Open Angle GlaucomaPhase 4SAF-24H-IOPNCT01162603

Latanoprost Versus Tafluprost: 24-hour Intraocular Pressure (IOP)

A Phase 4 study testing Goldmann and Perkins applanation tonometry, TAFLUPROST 0.0015% EYEDROPS and LATANOPROST 0.005% EYEDROPS in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Main objective is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular… Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Primary Open Angle Glaucoma, Ocular Hypertension
What is being tested?: Goldmann and Perkins applanation tonometry, TAFLUPROST 0.0015% EYEDROPS and LATANOPROST 0.005% EYEDROPS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesin 2 countries
Study dates: Mar 2011to Apr 2012
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients > 45 years
Damage of the optic nerve and alterations of the visual field in case of POAG, no defects at the optic nerve and at the visual field in case of OHT
Untreated IOP > 24 mm Hg but < 32 mm Hg in at least one eye at baseline (10AM) and central corneal thickness between 500 and 600 μm
Negative pregnancy test (fertile women). Fertile women attending the study must express clear will to avoid pregnancy during all the study period and in the next three months
Informed consent before starting the study

Who cannot join

Secondary glaucoma (Sturge-Weber syndrome, Neurofibromatosis I, neovascular glaucoma, steroid glaucoma, etc)
Anterior segment anomalies (cataract, irido-corneal disgenesy, congenital ectropion uvae, etc)
Past ocular surgery, except cataract surgery in the previous 6 months
Corneal abnormalities that can influence IOP measurements (corneal oedema)
Positive pregnancy test or breast-feeding woman. No will to avoid pregnancy during all the study period and in the next three months

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Greece1 site

Glaucoma Unit, 1st University Department of Ophthalmology, Aristotle University, AHEPA Hospital
Thessaloniki, 54636

Other trials in Greece

Italy1 site

USVD "Centro per lo studio del glaucoma" Spedali civili di Brescia
Brescia, 25123

Other trials in Italy

About this study

Official title: Comparative Evaluation of Intraocular Pressure During the 24 Hour in Patients Affected by Primary Open-angle Glaucoma and Ocular Hypertension: Latanoprost 0.005% Versus Tafluprost 0.0015% Ophthalmic Solutions

Main objective is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements.
Secondary objectives will be the comparison between Latanoprost 0.005% and Tafluprost 0.0015% ophthalmic solution about:
Mean 24-hour IOP values after three months of treatment
IOP values at these time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment

Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Being tested: Goldmann and Perkins applanation tonometry, TAFLUPROST 0.0015% EYEDROPS, LATANOPROST 0.005% EYEDROPS
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Goldmann and Perkins applanation tonometryDevice
Also called Saflutan, Merck Sharp & Dhome, Latanoprost 0.005% generic drug
IOP values will be assessed by the means of Goldmann or Perkins applanation tonometry at the following time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment
TAFLUPROST 0.0015% EYEDROPSDrug
Also called Saflutan, MSD
Tafluprost 0.0015% preservative-free ophthalmic solution
LATANOPROST 0.005% EYEDROPSDrug
Also called Latanoprost 0.005% eyedrops generic drug
Latanoprost 0.005% preservative-added ophthalmic solution

Study groups in NCT01162603
Study group	Role	What they receive
TAFLUPROST 0.0015% EYEDROPS	Experimental	Tafluprost 0.0015% preservative-free ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means of Goldmann and Perkins applanation tonometry. Receives: Device: Goldmann and Perkins applanation tonometry; Drug: TAFLUPROST 0.0015% EYEDROPS
LATANOPROST 0.005% EYEDROPS	Active comparator	Latanoprost 0.005% preservative-added ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means Goldmann and Perkins applanation tonometry. Receives: Device: Goldmann and Perkins applanation tonometry; Drug: LATANOPROST 0.005% EYEDROPS

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraocular Pressure
Primary endpoint of this crossover trial is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements.
Measured: 24-hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Apr 2012

First posted14 Jul 2010 (estimated)
Study startMar 2011
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Primary Open Angle 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01162603
Sponsor's protocol ID: AOBS-SAF-01
Acronym: SAF-24H-IOP
Status last verified: May 2013
First submitted: 13 Jul 2010
Last updated: 7 May 2013
Results posted: No
Data monitoring committee: No

Publications

Kuwayama Y, Komemushi S; Tafluprost Multi-center Study Group. [Intraocular pressure lowering effect of 0.0015% tafluprost as compared to placebo in patients with normal tension glaucoma: randomized, double-blind, multicenter, phase III study]. Nippon Ganka Gakkai Zasshi. 2010 May;114(5):436-43. Japanese.
PubMed 20545217
Uusitalo H, Pillunat LE, Ropo A; Phase III Study Investigators. Efficacy and safety of tafluprost 0.0015% versus latanoprost 0.005% eye drops in open-angle glaucoma and ocular hypertension: 24-month results of a randomized, double-masked phase III study. Acta Ophthalmol. 2010 Feb;88(1):12-9. doi: 10.1111/j.1755-3768.2010.01862.x.
PubMed 20420586
Aihara M. Clinical appraisal of tafluprost in the reduction of elevated intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension. Clin Ophthalmol. 2010 Mar 24;4:163-70. doi: 10.2147/opth.s6368.
PubMed 20390038
Hommer A, Mohammed Ramez O, Burchert M, Kimmich F. IOP-lowering efficacy and tolerability of preservative-free tafluprost 0.0015% among patients with ocular hypertension or glaucoma. Curr Med Res Opin. 2010 Aug;26(8):1905-13. doi: 10.1185/03007995.2010.492030.
PubMed 20553122
Konstas AG, Quaranta L, Katsanos A, Riva I, Tsai JC, Giannopoulos T, Voudouragkaki IC, Paschalinou E, Floriani I, Haidich AB. Twenty-four hour efficacy with preservative free tafluprost compared with latanoprost in patients with primary open angle glaucoma or ocular hypertension. Br J Ophthalmol. 2013 Dec;97(12):1510-5. doi: 10.1136/bjophthalmol-2012-303026. Epub 2013 May 16.
PubMed 23681371

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Evaluation of Intraocular Pressure During the 24 Hour in Patients Affected by Primary Open-angle Glaucoma and Ocular Hypertension: Latanoprost 0.005% Versus Tafluprost 0.0015% Ophthalmic Solutions
ClinicalTrials.gov ID: NCT01162603
Acronym / sponsor ID: SAF-24H-IOP / AOBS-SAF-01
Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
Collaborators: Aristotle University Of Thessaloniki
Study start: Mar 2011
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 14 Jul 2010 (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.

Main objective is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements.
Secondary objectives will be the comparison between Latanoprost 0.005% and Tafluprost 0.0015% ophthalmic solution about:
Mean 24-hour IOP values after three months of treatment
IOP values at these time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
TAFLUPROST 0.0015% EYEDROPS	Experimental	Device: Goldmann and Perkins applanation tonometry, Drug: TAFLUPROST 0.0015% EYEDROPSTafluprost 0.0015% preservative-free ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means of Goldmann and Perkins applanation tonometry.
LATANOPROST 0.005% EYEDROPS	Active comparator	Device: Goldmann and Perkins applanation tonometry, Drug: LATANOPROST 0.005% EYEDROPSLatanoprost 0.005% preservative-added ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means Goldmann and Perkins applanation tonometry.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male and female patients > 45 years
Damage of the optic nerve and alterations of the visual field in case of POAG, no defects at the optic nerve and at the visual field in case of OHT
Untreated IOP > 24 mm Hg but < 32 mm Hg in at least one eye at baseline (10AM) and central corneal thickness between 500 and 600 μm
Negative pregnancy test (fertile women). Fertile women attending the study must express clear will to avoid pregnancy during all the study period and in the next three months
Informed consent before starting the study

Key exclusion criteria (5 listed)

Secondary glaucoma (Sturge-Weber syndrome, Neurofibromatosis I, neovascular glaucoma, steroid glaucoma, etc)
Anterior segment anomalies (cataract, irido-corneal disgenesy, congenital ectropion uvae, etc)
Past ocular surgery, except cataract surgery in the previous 6 months
Corneal abnormalities that can influence IOP measurements (corneal oedema)
Positive pregnancy test or breast-feeding woman. No will to avoid pregnancy during all the study period and in the next three 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
Goldmann and Perkins applanation tonometryAlso: Saflutan, Merck Sharp & Dhome, Latanoprost 0.005% generic drugIOP values will be assessed by the means of Goldmann or Perkins applanation tonometry at the following time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment	Device	LATANOPROST 0.005% EYEDROPS, TAFLUPROST 0.0015% EYEDROPS
TAFLUPROST 0.0015% EYEDROPSAlso: Saflutan, MSDTafluprost 0.0015% preservative-free ophthalmic solution	Drug	TAFLUPROST 0.0015% EYEDROPS
LATANOPROST 0.005% EYEDROPSAlso: Latanoprost 0.005% eyedrops generic drugLatanoprost 0.005% preservative-added ophthalmic solution	Drug	LATANOPROST 0.005% EYEDROPS

Primary outcome

Intraocular Pressure
Time frame: 24-hour
Primary endpoint of this crossover trial is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements.

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 7 May 2013.
Background: PubMed 20545217Kuwayama Y, Komemushi S; Tafluprost Multi-center Study Group. [Intraocular pressure lowering effect of 0.0015% tafluprost as compared to placebo in patients with normal tension glaucoma: randomized, double-blind, multicenter, phase III study]. Nippon Ganka Gakkai Zasshi. 2010 May;114(5):436-43. Japanese.
Background: PubMed 20420586Uusitalo H, Pillunat LE, Ropo A; Phase III Study Investigators. Efficacy and safety of tafluprost 0.0015% versus latanoprost 0.005% eye drops in open-angle glaucoma and ocular hypertension: 24-month results of a randomized, double-masked phase III study. Acta Ophthalmol. 2010 Feb;88(1):12-9. doi: 10.1111/j.1755-3768.2010.01862.x.
Background: PubMed 20390038Aihara M. Clinical appraisal of tafluprost in the reduction of elevated intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension. Clin Ophthalmol. 2010 Mar 24;4:163-70. doi: 10.2147/opth.s6368.
Results publication: PubMed 20553122Hommer A, Mohammed Ramez O, Burchert M, Kimmich F. IOP-lowering efficacy and tolerability of preservative-free tafluprost 0.0015% among patients with ocular hypertension or glaucoma. Curr Med Res Opin. 2010 Aug;26(8):1905-13. doi: 10.1185/03007995.2010.492030.
Derived from this study: PubMed 23681371Konstas AG, Quaranta L, Katsanos A, Riva I, Tsai JC, Giannopoulos T, Voudouragkaki IC, Paschalinou E, Floriani I, Haidich AB. Twenty-four hour efficacy with preservative free tafluprost compared with latanoprost in patients with primary open angle glaucoma or ocular hypertension. Br J Ophthalmol. 2013 Dec;97(12):1510-5. doi: 10.1136/bjophthalmol-2012-303026. Epub 2013 May 16.

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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.

Luciano Quaranta, MD principal investigator

Università degli Studi di Brescia

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece, 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?

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?

Intraocular Pressure (time frame: 24-hour). 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 NCT01162603, which also lists 5 linked publications.

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 7 May 2013.