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

NCT ID: NCT02802137

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-01-31

Brief 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.

Conditions

Glaucoma; Ocular Surface Disease

Keywords

tafluprost; dorzolamide; timolol; FC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tafluprost drops

Treatment with preservative-free talfuprost drops administered once in the evening. Evaluation of 24-hour efficacy and ocular surface health after 3 months of therapy.

Group Type: ACTIVE_COMPARATOR

tafluprost

Intervention Type: DRUG

Tafluprost and dorzolamide/timolol drops

Concomitant therapy with preservative-free talfuprost drops administered once in the evening and dorzolamide/timolol fixed combination drops given twice daily. Evaluation of 24-hour efficacy and ocular surface health after 3 months of therapy.

Group Type: ACTIVE_COMPARATOR

tafluprost and dorzolamide/timolol

Intervention Type: DRUG

Interventions

tafluprost

Intervention Type: DRUG

tafluprost and dorzolamide/timolol

Intervention Type: DRUG

Other Intervention Names

Saflutan, Taflotan; Saflutan, Taflotan, Cosopt PF

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

AGP Konstas

Professor AGP Konstas

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anastasios G Konstas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chair

References

Konstas AG, Boboridis KG, Kapis P, Marinopoulos K, Voudouragkaki IC, Panayiotou D, Mikropoulos DG, Pagkalidou E, Haidich AB, Katsanos A, Quaranta L. 24-Hour Efficacy and Ocular Surface Health with Preservative-Free Tafluprost Alone and in Conjunction with Preservative-Free Dorzolamide/Timolol Fixed Combination in Open-Angle Glaucoma Patients Insufficiently Controlled with Preserved Latanoprost Monotherapy. Adv Ther. 2017 Jan;34(1):221-235. doi: 10.1007/s12325-016-0448-9. Epub 2016 Dec 2.

Reference Type: DERIVED

PMID: 27913991 (View on PubMed)

Other Identifiers

16/5.3.2015

Identifier Type: -

Identifier Source: org_study_id