24-hour efficacy and ocular surface with talfuprost and triple combined therapy

Conditions: Glaucoma; Ocular Surface Disease

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.


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.

Keywords: tafluprost dorzolamide timolol fc