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OpenTrials
Completed

NCT Number: NCT02802137

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

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.

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tafluprost

Drug

Other names: Saflutan, Taflotan

tafluprost and dorzolamide/timolol

Drug

Other names: Saflutan, Taflotan, Cosopt PF

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. Mean 24-hour peak intraocular pressure

    Time frame: 3 months

  2. Mean 24-hour fluctuation of intraocular pressure

    Time frame: 3 months

  3. Corneal staining

    Time frame: 3 months

  4. Break-up time of tear film

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 16, 2016
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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