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

Phase 4

Completed

• Conditions: Glaucoma; Ocular Surface Disease
• Interventions: Drug: tafluprost; Drug: tafluprost and dorzolamide/timolol

• Registration Number: NCT02802137
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-16
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tafluprost drops	tafluprost	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.
Tafluprost and dorzolamide/timolol drops	tafluprost and dorzolamide/timolol	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.

Primary Outcome Measures

Name	Time	Method
Mean 24-hour efficacy (average intraocular pressure readings over 24 hours)	3 months

Secondary Outcome Measures

Name	Time	Method
Mean 24-hour peak intraocular pressure	3 months
Mean 24-hour fluctuation of intraocular pressure	3 months
Break-up time of tear film	3 months
Corneal staining	3 months