Primary Open-angle GlaucomaPhase 4NCT03104621
Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients
A Phase 4 study testing Benzalkonium chloride (BAK) and 0.0015% tafluprost in people with Primary Open-angle Glaucoma, run by Gangnam Severance Hospital.
Trial summary
The aim of this work is to evaluate efficacy and tolerability of preservative containing 0.0015% tafluprost and preservative-free 0.0015% tafluprost. Both preservative containing and preservative-free 0.0015% tafluprost will reduce intraocular pressure significantly. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- Benzalkonium chloride (BAK) and 0.0015% tafluprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Sep 2015
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Primary open angle glaucoma and normotensive glaucoma patients who came to the outpatient clinic for regular glaucoma check-ups were enrolled.
- 2. Glaucoma was defined as the patients who had open angle confirmed by gonioscopy, optic nerve cupping (a vertical cup-disc ratio of >0.6) and or notching of the neuroretinal rim and or retinal nerve fiber defects characteristics of glaucoma, and visual field defect(i.e., a glaucoma hemi-filed test result outside normal limits, a pattern standard deviation probability of <5%, or a cluster of three or more non-edge points in location typical of glaucoma, all of which were depressed on a pattern deviation plot at a P level of <5%, and at least one of which was depressed at a P level of <1% on two consecutive visual field tests).
- 3. Normal tension glaucoma included criteria: repeated measurements of untreated IOP values of < 21mmHg. Primary open angle glaucoma included criteria: repeated measurements of untreated IOP values of ≥ 22mmHg.
Who cannot join
- 1. Phakic and pseudophakic eyes.
- 2. eyes that had been taken vitrectomy, trabeculectomy, or surgery influenced IOP
About this study
The aim of this work is to evaluate efficacy and tolerability of preservative containing 0.0015% tafluprost and preservative-free 0.0015% tafluprost. Both preservative containing and preservative-free 0.0015% tafluprost will reduce intraocular pressure significantly. In addition, preservative-free 0.0015% tafluprost might improve tolerability of glaucoma patients.
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- Benzalkonium chloride (BAK), 0.0015% tafluprost
- Keywords
- preservative-free, tafluprost
- 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.
Benzalkonium chloride (BAK)Drug
Benzalkonium chloride (BAK) is the most used preservative and is excellent for safety and stability of drug. However, it causes dry eye, corneal oedema, corneal erosion, and corneal toxicities, thus lowering the long-term tolerability for patients. A critical component when managing glaucoma patients is ensuring compliance.
0.0015% tafluprostDrug
Tafluprost (trade names Taflotan or Taflotan-S by Santen Pharmaceutical) is a prostaglandin analogue. It is used topically (as eye drops) to control the progression of open-angle glaucoma and in the management of ocular hypertension. In this study, tafluprost was used in all experimental group with equally concentration(0.0015%), only measured whether BAK was included or not.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1, for the first 6 months, the subjects of group 1 used non-preservative disposable 0.0015% tafluprost product(Taflotan-S®) and then changed to 0.001% Benzalkonium chloride (BAK), 0.0015% tafluprost product (Taflotan®)for 6 months. Receives: Drug: Benzalkonium chloride (BAK); Drug: 0.0015% tafluprost |
| Group 2 | Experimental | Group 2, for the first 6 months, the subjects of group 2 used 0.001% Benzalkonium chloride (BAK), 0.0015% tafluprost product(Taflotan®) and then changed to non-preservative disposable 0.0015% tafluprost product(Taflotan-S®) for 6 months. Receives: Drug: Benzalkonium chloride (BAK); Drug: 0.0015% tafluprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of corneal erosion grade by preservative free 0.0015% tafluprost
Corneal erosion scales were scored according to the area of erosion. Little to no erosion was "0", erosion on 1/3 of the area of the entire cornea was "1", erosion on 2/3 of the area of the entire cornea was "2", and erosion on the entire cornea was "3"
Measured: after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2
The change of tear break up time by preservative free 0.0015% tafluprost
Tear breakup time was checked by slit lamp exam under corneal fluorescein dye. We asked patients not to blink, and the time was counted until tear film was torn apart (seconds)
Measured: after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2
The change of Schirmer test by preservative free 0.0015% tafluprost
For tear secretion, schirmer test paper was placed into the conjunctival sac at the point of 1/3 from lateral canthus under topical anaesthesia (5% Proparacaine HCl, Alcaine®, Alcon Laboratories Inc., TX, USA). After 5 minutes, we checked the wet height with tear (mm)
Measured: after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2
The change of corneal erosion grade by preservative contained 0.0015% tafluprost
Corneal erosion scales were scored according to the area of erosion. Little to no erosion was "0", erosion on 1/3 of the area of the entire cornea was "1", erosion on 2/3 of the area of the entire cornea was "2", and erosion on the entire cornea was "3"
Measured: after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1
The change of tear break up time by preservative contained 0.0015% tafluprost
Tear breakup time was checked by slit lamp exam under corneal fluorescein dye. We asked patients not to blink, and the time was counted until tear film was torn apart (seconds)
Measured: after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1
The change of Schirmer test by preservative contained 0.0015% tafluprost
or tear secretion, schirmer test paper was placed into the conjunctival sac at the point of 1/3 from lateral canthus under topical anaesthesia (5% Proparacaine HCl, Alcaine®, Alcon Laboratories Inc., TX, USA). After 5 minutes, we checked the wet height with tear (mm)
Measured: after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startMar 2013
- Primary completionSep 2014
- Study completionSep 2015
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gong Je Seong, Gangnam Severance Hospital
- Investigators
- Gong Je Seong, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104621
- Sponsor's protocol ID
- 3-2013-0042
- Status last verified
- Apr 2017
- First submitted
- 13 Mar 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee W, Lee S, Bae H, Kim CY, Seong GJ. Efficacy and tolerability of preservative-free 0.0015% tafluprost in glaucoma patients: a prospective crossover study. BMC Ophthalmol. 2017 Apr 28;17(1):61. doi: 10.1186/s12886-017-0453-z.
PubMed 28454526
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT03104621
- Acronym / sponsor ID
- 3-2013-0042
- Conditions
- Primary Open-angle Glaucoma
- Keywords
- preservative-free, tafluprost
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Apr 2017 (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 aim of this work is to evaluate efficacy and tolerability of preservative containing 0.0015% tafluprost and preservative-free 0.0015% tafluprost. Both preservative containing and preservative-free 0.0015% tafluprost will reduce intraocular pressure significantly. In addition, preservative-free 0.0015% tafluprost might improve tolerability of glaucoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Benzalkonium chloride (BAK), Drug: 0.0015% tafluprostGroup 1, for the first 6 months, the subjects of group 1 used non-preservative disposable 0.0015% tafluprost product(Taflotan-S®) and then changed to 0.001% Benzalkonium chloride (BAK), 0.0015% tafluprost product (Taflotan®)for 6 months. |
| Group 2 | Experimental | Drug: Benzalkonium chloride (BAK), Drug: 0.0015% tafluprostGroup 2, for the first 6 months, the subjects of group 2 used 0.001% Benzalkonium chloride (BAK), 0.0015% tafluprost product(Taflotan®) and then changed to non-preservative disposable 0.0015% tafluprost product(Taflotan-S®) for 6 months. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Primary open angle glaucoma and normotensive glaucoma patients who came to the outpatient clinic for regular glaucoma check-ups were enrolled.
- 2. Glaucoma was defined as the patients who had open angle confirmed by gonioscopy, optic nerve cupping (a vertical cup-disc ratio of >0.6) and or notching of the neuroretinal rim and or retinal nerve fiber defects characteristics of glaucoma, and visual field defect(i.e., a glaucoma hemi-filed test result outside normal limits, a pattern standard deviation probability of <5%, or a cluster of three or more non-edge points in location typical of glaucoma, all of which were depressed on a pattern deviation plot at a P level of <5%, and at least one of which was depressed at a P level of <1% on two consecutive visual field tests).
- 3. Normal tension glaucoma included criteria: repeated measurements of untreated IOP values of < 21mmHg. Primary open angle glaucoma included criteria: repeated measurements of untreated IOP values of ≥ 22mmHg.
Key exclusion criteria (2 listed)
- 1. Phakic and pseudophakic eyes.
- 2. eyes that had been taken vitrectomy, trabeculectomy, or surgery influenced IOP
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 |
|---|---|---|
| Benzalkonium chloride (BAK)Benzalkonium chloride (BAK) is the most used preservative and is excellent for safety and stability of drug. However, it causes dry eye, corneal oedema, corneal erosion, and corneal toxicities, thus lowering the long-term tolerability for patients. A critical component when managing glaucoma patients is ensuring compliance. | Drug | Group 1, Group 2 |
| 0.0015% tafluprostTafluprost (trade names Taflotan or Taflotan-S by Santen Pharmaceutical) is a prostaglandin analogue. It is used topically (as eye drops) to control the progression of open-angle glaucoma and in the management of ocular hypertension. In this study, tafluprost was used in all experimental group with equally concentration(0.0015%), only measured whether BAK was included or not. | Drug | Group 1, Group 2 |
Primary outcome
The change of corneal erosion grade by preservative free 0.0015% tafluprost
Time frame: after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2
Corneal erosion scales were scored according to the area of erosion. Little to no erosion was "0", erosion on 1/3 of the area of the entire cornea was "1", erosion on 2/3 of the area of the entire cornea was "2", and erosion on the entire cornea was "3"
The change of tear break up time by preservative free 0.0015% tafluprost
Time frame: after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2
Tear breakup time was checked by slit lamp exam under corneal fluorescein dye. We asked patients not to blink, and the time was counted until tear film was torn apart (seconds)
The change of Schirmer test by preservative free 0.0015% tafluprost
Time frame: after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2
For tear secretion, schirmer test paper was placed into the conjunctival sac at the point of 1/3 from lateral canthus under topical anaesthesia (5% Proparacaine HCl, Alcaine®, Alcon Laboratories Inc., TX, USA). After 5 minutes, we checked the wet height with tear (mm)
The change of corneal erosion grade by preservative contained 0.0015% tafluprost
Time frame: after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1
Corneal erosion scales were scored according to the area of erosion. Little to no erosion was "0", erosion on 1/3 of the area of the entire cornea was "1", erosion on 2/3 of the area of the entire cornea was "2", and erosion on the entire cornea was "3"
The change of tear break up time by preservative contained 0.0015% tafluprost
Time frame: after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1
Tear breakup time was checked by slit lamp exam under corneal fluorescein dye. We asked patients not to blink, and the time was counted until tear film was torn apart (seconds)
The change of Schirmer test by preservative contained 0.0015% tafluprost
Time frame: after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1
or tear secretion, schirmer test paper was placed into the conjunctival sac at the point of 1/3 from lateral canthus under topical anaesthesia (5% Proparacaine HCl, Alcaine®, Alcon Laboratories Inc., TX, USA). After 5 minutes, we checked the wet height with tear (mm)
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 Apr 2017.
- Derived from this study: PubMed 28454526Lee W, Lee S, Bae H, Kim CY, Seong GJ. Efficacy and tolerability of preservative-free 0.0015% tafluprost in glaucoma patients: a prospective crossover study. BMC Ophthalmol. 2017 Apr 28;17(1):61. doi: 10.1186/s12886-017-0453-z.
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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.
Gong Je Seong principal investigator
Gangnam Severance Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benzalkonium chloride (BAK) and 0.0015% tafluprost in people with Primary Open-angle Glaucoma, run by Gangnam Severance Hospital.
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 3 inclusion and 2 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 Apr 2017. 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?
The change of corneal erosion grade by preservative free 0.0015% tafluprost (time frame: after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2). The study lists 6 primary outcomes in all. 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 NCT03104621, 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 7 Apr 2017.