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

NCT02802137 | Completed Phase 4

• 1 other identifier: 16/5.3.2015
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Mean 24-hour efficacy (average intraocular pressure readings over 24 hours)

  3 months

Secondary Outcomes (4)

• Mean 24-hour peak intraocular pressure

  3 months

• Mean 24-hour fluctuation of intraocular pressure

  3 months

• Corneal staining

  3 months

• Break-up time of tear film

  3 months

Study Arms (2)

Tafluprost drops

ACTIVE COMPARATOR

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.

Drug: tafluprost

Tafluprost and dorzolamide/timolol drops

ACTIVE COMPARATOR

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.

Drug: tafluprost and dorzolamide/timolol

Interventions

tafluprost DRUG

Also known as: Saflutan, Taflotan

Tafluprost drops

tafluprost and dorzolamide/timolol DRUG

Also known as: Saflutan, Taflotan, Cosopt PF

Tafluprost and dorzolamide/timolol drops

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Related Publications (1)

• 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.

  PMID: 27913991 DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

tafluprost; dorzolamide; Timolol; dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Anastasios G Konstas, MD, PhD

  Chair

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor AGP Konstas

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 16, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share