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
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 |
Verified date | December 2020 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
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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