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Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients

Primary Purpose

Primary Open-angle Glaucoma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Benzalkonium chloride (BAK)
0.0015% tafluprost
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring preservative-free, tafluprost

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 1. Phakic and pseudophakic eyes.
  • 2. eyes that had been taken vitrectomy, trabeculectomy, or surgery influenced IOP

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group 1

    Group 2

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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"
    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)
    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)
    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"
    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)
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 13, 2017
    Last Updated
    April 1, 2017
    Sponsor
    Gangnam Severance Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03104621
    Brief Title
    Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients
    Official Title
    Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (Actual)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gangnam Severance Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. In addition, preservative-free 0.0015% tafluprost might improve tolerability of glaucoma patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Open-angle Glaucoma
    Keywords
    preservative-free, tafluprost

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Investigators, patients and other study participants were blinded to treatment assignment throughout the study. Evaluator of IOP was also masked to treatment assignment.
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Benzalkonium chloride (BAK)
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    0.0015% tafluprost
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The change of corneal erosion grade by preservative free 0.0015% tafluprost
    Description
    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"
    Time Frame
    after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2
    Title
    The change of tear break up time by preservative free 0.0015% tafluprost
    Description
    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)
    Time Frame
    after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2
    Title
    The change of Schirmer test by preservative free 0.0015% tafluprost
    Description
    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)
    Time Frame
    after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2
    Title
    The change of corneal erosion grade by preservative contained 0.0015% tafluprost
    Description
    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"
    Time Frame
    after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1
    Title
    The change of tear break up time by preservative contained 0.0015% tafluprost
    Description
    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)
    Time Frame
    after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1
    Title
    The change of Schirmer test by preservative contained 0.0015% tafluprost
    Description
    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)
    Time Frame
    after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 1. Phakic and pseudophakic eyes. 2. eyes that had been taken vitrectomy, trabeculectomy, or surgery influenced IOP
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gong Je Seong
    Organizational Affiliation
    Gangnam Severance Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28454526
    Citation
    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.
    Results Reference
    derived

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    Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients

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