GlaucomaPhase 4NCT02802137

24-hour Efficacy and Ocular Surface With Talfuprost and Triple Combined Therapy

A Phase 4 study testing tafluprost and tafluprost and dorzolamide/timolol in people with Glaucoma and Ocular Surface Disease, run by Aristotle University Of Thessaloniki.

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

Who is it for?: Ages 21 to 85 years
Conditions the study is for: Glaucoma, Ocular Surface Disease
What is being tested?: tafluprost and tafluprost and dorzolamide/timolol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: No sites listed yet
Study dates: Mar 2015to Jan 2016
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

Open-angle glaucoma patients (primary open-angle glaucoma, exfoliative, or pigmentary glaucoma) insufficiently controlled on branded, or generic latanoprost monotherapy (IOP > 20 mm Hg as determined by 2 separate IOP measurements at 10:00 ± 1 hour)
Patients with signs, or symptoms of ocular surface disease.
Only those open-angle glaucoma subjects who, according to the opinion of the principal investigator, require further IOP reduction.
Patients must have demonstrated at least 20% IOP reduction at 10:00 (± 1 hour) and who are treated with branded, or generic latanoprost monotherapy for at least 3 months.
Only subjects with open-angle glaucoma that have exhibited (prior to latanoprost therapy) untreated, sitting IOP evaluated with Goldmann tonometry between 25-39 mm Hg at 10:00 (± 1 hour).
Age between 21-85 years

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Mild to moderate glaucomatous disc damage and visual field loss (less than -12 dB mean deviation visual field loss attributed to glaucoma
Those with 0.8 or better vertical cup-to-disc ratio and visual acuity greater than 0.1 in the study eye.
Open anterior chamber angles.
Those who have to demonstrate a reliable visual field (at least two visual fields with less than 20% fixation losses, false positives, or negatives)
Patients who understand study instructions, are willing to attend all follow-up appointments and will comply with study medication usage.

Who cannot join

Patients with a history of less than 10% IOP decrease on any IOP-lowering medication.
Those with evidence of concurrent conjunctivitis, keratitis, or uveitis in either eye.
Subjects with a history of inadequate adherence; intolerance, or contraindication to either prostaglandins, β-blockers, dorzolamide, or benzalconium chloride (BAK)
Patients with severe ocular surface disease, previous 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.
Those that on baseline examination show clinical evidence of inflammation, signs of ocular infection (except blepharitis), signs of any corneal abnormality that will affect subsequent IOP measurements
Subjects that show unwillingness to participate in the trial.
Females of childbearing potential or lactating mothers.

About this study

Official title: 24-hour Efficacy and Ocular Surface Health With PF Tafluprost and Combined Therapy With PF Tafluprost and Dorzolamide/Timolol Fixed Combination in Open-angle Glaucoma Subjects Insufficiently Controlled With Latanoprost

The study investigated the 24-hour efficacy and ocular surface health with preservative-free tafluprost and a combined preservative-free regimen (tafluprost and dorzolamide/timolol fixed combination) in open-angle glaucoma patients insufficiently controlled on latanoprost monotherapy and showing signs, or symptoms of ocular surface disease with preservative-containing latanoprost monotherapy. This trial randomized open-angle glaucoma patients insufficiently controlled (IOP > 20 mm Hg) on branded, or generic latanoprost monotherapy who required further IOP reduction and who demonstrated clinical signs, or symptoms of ocular surface disease.

Conditions: Glaucoma, Ocular Surface Disease
Being tested: tafluprost, tafluprost and dorzolamide/timolol
Keywords: tafluprost, dorzolamide, timolol, FC
Medical subject headings: Glaucoma

What participants receive

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

tafluprostDrug
Also called Saflutan, Taflotan
tafluprost and dorzolamide/timololDrug
Also called Saflutan, Taflotan, Cosopt PF

Study groups in NCT02802137
Study group	Role	What they receive
Tafluprost drops	Active comparator	Treatment with preservative-free talfuprost drops administered once in the evening. Evaluation of 24-hour efficacy and ocular surface health after 3 months of therapy. Receives: Drug: tafluprost
Tafluprost and dorzolamide/timolol drops	Active comparator	Concomitant therapy with preservative-free talfuprost drops administered once in the evening and dorzolamide/timolol fixed combination drops given twice daily. Evaluation of 24-hour efficacy and ocular surface health after 3 months of therapy. Receives: Drug: tafluprost and dorzolamide/timolol

What is being measured

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

Mean 24-hour efficacy (average intraocular pressure readings over 24 hours)
Measured: 3 months

Secondary outcomes (4)

Mean 24-hour peak intraocular pressure
Measured: 3 months
Mean 24-hour fluctuation of intraocular pressure
Measured: 3 months
Corneal staining
Measured: 3 months
Break-up time of tear film
Measured: 3 months

Timeline

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

Mar 2015Jan 2016

First posted16 Jun 2016 (estimated)
Study startMar 2015
Primary completionDec 2015
Study completionJan 2016

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.
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: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02802137
Sponsor's protocol ID: 16/5.3.2015
Status last verified: Dec 2020
First submitted: 8 Jun 2016
Last updated: 17 Dec 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Konstas AG, Boboridis KG, Kapis P, Marinopoulos K, Voudouragkaki IC, Panayiotou D, Mikropoulos DG, Pagkalidou E, Haidich AB, Katsanos A, Quaranta L. 24-Hour Efficacy and Ocular Surface Health with Preservative-Free Tafluprost Alone and in Conjunction with Preservative-Free Dorzolamide/Timolol Fixed Combination in Open-Angle Glaucoma Patients Insufficiently Controlled with Preserved Latanoprost Monotherapy. Adv Ther. 2017 Jan;34(1):221-235. doi: 10.1007/s12325-016-0448-9. Epub 2016 Dec 2.
PubMed 27913991

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?

Official record

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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 Efficacy and Ocular Surface Health With PF Tafluprost and Combined Therapy With PF Tafluprost and Dorzolamide/Timolol Fixed Combination in Open-angle Glaucoma Subjects Insufficiently Controlled With Latanoprost
ClinicalTrials.gov ID: NCT02802137
Acronym / sponsor ID: 16/5.3.2015
Conditions: Glaucoma, Ocular Surface Disease
Keywords: tafluprost, dorzolamide, timolol, FC
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Aristotle University Of ThessalonikiUniversity, hospital or other
Study start: Mar 2015 (actual)
Primary completion: Dec 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 16 Jun 2016 (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.

Study design

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

Arm	Type	Receives
Tafluprost drops	Active comparator	Drug: tafluprostTreatment with preservative-free talfuprost drops administered once in the evening. Evaluation of 24-hour efficacy and ocular surface health after 3 months of therapy.
Tafluprost and dorzolamide/timolol drops	Active comparator	Drug: tafluprost and dorzolamide/timololConcomitant therapy with preservative-free talfuprost drops administered once in the evening and dorzolamide/timolol fixed combination drops given twice daily. Evaluation of 24-hour efficacy and ocular surface health after 3 months of therapy.

Who may qualify

Ages: 21 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Open-angle glaucoma patients (primary open-angle glaucoma, exfoliative, or pigmentary glaucoma) insufficiently controlled on branded, or generic latanoprost monotherapy (IOP > 20 mm Hg as determined by 2 separate IOP measurements at 10:00 ± 1 hour)
Patients with signs, or symptoms of ocular surface disease.
Only those open-angle glaucoma subjects who, according to the opinion of the principal investigator, require further IOP reduction.
Patients must have demonstrated at least 20% IOP reduction at 10:00 (± 1 hour) and who are treated with branded, or generic latanoprost monotherapy for at least 3 months.
Only subjects with open-angle glaucoma that have exhibited (prior to latanoprost therapy) untreated, sitting IOP evaluated with Goldmann tonometry between 25-39 mm Hg at 10:00 (± 1 hour).

Key exclusion criteria (7 listed)

Patients with a history of less than 10% IOP decrease on any IOP-lowering medication.
Those with evidence of concurrent conjunctivitis, keratitis, or uveitis in either eye.
Subjects with a history of inadequate adherence; intolerance, or contraindication to either prostaglandins, β-blockers, dorzolamide, or benzalconium chloride (BAK)
Patients with severe ocular surface disease, previous 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.
Those that on baseline examination show clinical evidence of inflammation, signs of ocular infection (except blepharitis), signs of any corneal abnormality that will affect subsequent IOP measurements

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
tafluprostAlso: Saflutan, Taflotan	Drug	Tafluprost drops
tafluprost and dorzolamide/timololAlso: Saflutan, Taflotan, Cosopt PF	Drug	Tafluprost and dorzolamide/timolol drops

Primary outcome

Mean 24-hour efficacy (average intraocular pressure readings over 24 hours)
Time frame: 3 months

4 secondary outcomes

Mean 24-hour peak intraocular pressure
Time frame: 3 months
Mean 24-hour fluctuation of intraocular pressure
Time frame: 3 months
Corneal staining
Time frame: 3 months
Break-up time of tear film
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.
Derived from this study: PubMed 27913991Konstas AG, Boboridis KG, Kapis P, Marinopoulos K, Voudouragkaki IC, Panayiotou D, Mikropoulos DG, Pagkalidou E, Haidich AB, Katsanos A, Quaranta L. 24-Hour Efficacy and Ocular Surface Health with Preservative-Free Tafluprost Alone and in Conjunction with Preservative-Free Dorzolamide/Timolol Fixed Combination in Open-Angle Glaucoma Patients Insufficiently Controlled with Preserved Latanoprost Monotherapy. Adv Ther. 2017 Jan;34(1):221-235. doi: 10.1007/s12325-016-0448-9. Epub 2016 Dec 2.
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.

Anastasios G Konstas, MD, PhD principal investigator

Chair

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tafluprost and tafluprost and dorzolamide/timolol in people with Glaucoma and Ocular Surface Disease, 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 11 inclusion and 7 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?

Mean 24-hour efficacy (average intraocular pressure readings over 24 hours) (time frame: 3 months). 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 NCT02802137, 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.