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

Sponsor

Aristotle University Of Thessaloniki (Other)

Overall Status

Completed

CT.gov ID

NCT02802137

Collaborator

(none)

Enrollment

Arms

10.1

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Ocular Surface Disease	Drug: tafluprost Drug: tafluprost and dorzolamide/timolol	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: tafluprost Other Names: Saflutan, Taflotan
Active Comparator: 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.	Drug: tafluprost and dorzolamide/timolol Other Names: Saflutan, Taflotan, Cosopt PF

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: tafluprost

Other Names:

Saflutan, Taflotan

Active Comparator: 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.

Drug: tafluprost and dorzolamide/timolol

Other Names:

Saflutan, Taflotan, Cosopt PF

Outcome Measures

Primary Outcome Measures

Mean 24-hour efficacy (average intraocular pressure readings over 24 hours) [3 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.