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

Primary Purpose

Glaucoma, Ocular Surface Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
tafluprost
tafluprost and dorzolamide/timolol
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring tafluprost, dorzolamide, timolol, FC

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Tafluprost drops

    Tafluprost and dorzolamide/timolol drops

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Mean 24-hour efficacy (average intraocular pressure readings over 24 hours)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 8, 2016
    Last Updated
    December 16, 2020
    Sponsor
    Aristotle University Of Thessaloniki
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02802137
    Brief Title
    24-hour Efficacy and Ocular Surface With Talfuprost and Triple Combined Therapy
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (Actual)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aristotle University Of Thessaloniki

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Ocular Surface Disease
    Keywords
    tafluprost, dorzolamide, timolol, FC

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tafluprost drops
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Tafluprost and dorzolamide/timolol drops
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    tafluprost
    Other Intervention Name(s)
    Saflutan, Taflotan
    Intervention Type
    Drug
    Intervention Name(s)
    tafluprost and dorzolamide/timolol
    Other Intervention Name(s)
    Saflutan, Taflotan, Cosopt PF
    Primary Outcome Measure Information:
    Title
    Mean 24-hour efficacy (average intraocular pressure readings over 24 hours)
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Mean 24-hour peak intraocular pressure
    Time Frame
    3 months
    Title
    Mean 24-hour fluctuation of intraocular pressure
    Time Frame
    3 months
    Title
    Corneal staining
    Time Frame
    3 months
    Title
    Break-up time of tear film
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria 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 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. Exclusion criteria 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anastasios G Konstas, MD, PhD
    Organizational Affiliation
    Chair
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27913991
    Citation
    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. Erratum In: Adv Ther. 2020 May;37(5):2572-2573.
    Results Reference
    derived

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

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