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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802137
• Other study ID #: 16/5.3.2015
• Status: Completed
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: December 2020
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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, ß-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.

Related Conditions & MeSH terms

• Glaucoma
• Ocular Surface Disease

Intervention

Drug:
• tafluprost

• tafluprost and dorzolamide/timolol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24-hour efficacy (average intraocular pressure readings over 24 hours)		3 months
Secondary	Mean 24-hour peak intraocular pressure		3 months
Secondary	Mean 24-hour fluctuation of intraocular pressure		3 months
Secondary	Corneal staining		3 months
Secondary	Break-up time of tear film		3 months