24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost

Glaucoma Clinical Trial

Official title:

A Crossover, Double-Masked Comparison Investigating the 24-Hour Intraocular Pressure Control With the Travoprost/Timolol Fixed Combination Versus Travoprost, When Both Are Given in the Evening, in Subjects With Primary Open-Angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444184
• Other study ID #: A3243
• Status: Completed
• Phase: Phase 4
• First received: March 5, 2007
• Last updated: May 9, 2014
• Start date: March 2007
• Est. completion date: January 2008

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

This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 29 Years to 81 Years

Eligibility

Inclusion Criteria:

• Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00).

• Patient has POAG and is older than 29 years

• The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00)

• Patient can be safely washed out without risk for significant deterioration

• Distance best corrected Snellen visual acuity better than 1/10

• Patient can understand the instructions and comply to medications

• Open normal appearing angles

Exclusion Criteria:

• Contraindications to prostaglandins or ß-blockers

• History of lack of response (<10% reduction) to any medication

• Female of childbearing potential or lactating mother

• History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses

• Sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Travoprost/timolol fixed combination, travoprost

Locations

Country	Name	City	State
Greece	Glaucoma Unit, 1st University Department of Ophthalmology	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Alcon Research

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24-hour IOP		3 months	No
Secondary	Mean reduction from baseline		3 months	No
Secondary	Mean fluctuation of 24-hour IOP		3 months	No
Secondary	Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.		3 months	No