Preservative-free Tafluprost/Timolol Fixed Combination: Morning vs Evening Dosing

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The ideal dosing for preservative-free tafluprost/timolol fixed combination remains to be elucidated. The present study compared the 24-hour intraocular pressure efficacy obtained with tafluprost/timolol given once in the evening with placebo once in the morning, versus that with the same fixed combination administered once in the morning with placebo given once in the evening in consecutive patients with open-angle glaucoma insufficiently controlled with branded, or generic latanoprost monotherapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aristotle University Of Thessaloniki
• Collaborator: Santen Oy
• Treatments: Timolol

Criteria

Inclusion Criteria:

1. age between 21-85 years;

2. mild to moderate glaucomatous disc damage and visual field loss (less than -12 dB mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio);

3. visual acuity greater than 0.1 in the study eye;

4. open anterior chamber angles;

5. in each patient the diagnosis of open-angle glaucoma will be made by the principal investigator based on the European Glaucoma Society criteria;

6. study patients will have to demonstrate a reliable visual field (at least two visual fields with less than 20% fixation losses, false positives, or negatives);

7. patient should understand the study instructions and to be willing to attend all follow-up appointments and should be willing to comply with study medication usage.

Exclusion Criteria:

1. previous history of less than 10% IOP decrease on any IOP-lowering medication;

2. evidence of concurrent conjunctivitis, keratitis, or uveitis in either eye;

3. history of inadequate adherence; intolerance, or contraindication to either prostaglandins, β-blockers, dorzolamide, or benzalconium chloride (BAK);

4. severe ocular surface disease, intraocular conventional or laser surgery in the study eye (within 6 months prior to enrolment);

5. previous history of ocular trauma;

6. use of corticosteroids (within 3 months before the enrolment) and use of contact lenses;

7. patients will also be excluded if on baseline exam they show clinical evidence of inflammation, signs of ocular infection (except blepharitis), signs of any corneal abnormality that will affect subsequent IOP measurements;

8. unwillingness to participate in the trial;

9. females of childbearing potential or lactating mothers.