24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination

Primary Open Angle Glaucoma Clinical Trial

Official title:

24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331240
• Other study ID #: A1457
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2006
• Last updated: May 9, 2014
• Start date: March 2006
• Est. completion date: February 2007

Study information

• Verified date: May 2014
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the short-term (8 week) mean 24-hour intraocular pressure control and safety of TravTim fixed combination given once in the evening with placebo once in the morning versus TravTim given once in the morning with placebo once in the evening in patients with open-angle glaucoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 29 Years to 80 Years

Eligibility

Inclusion Criteria:

• POAG

• Exfoliation syndrome

Exclusion Criteria:

• Advanced glaucoma

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Drug:
• travoprost/timolol fixed combination

• placebo (artificial tears)

Locations

Country	Name	City	State
Greece	Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece,