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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02802137
Other study ID # 16/5.3.2015
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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