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”

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 our 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: Travoprost/timolol fixed combination, travoprost

Primary Measures

• Mean 24-hour IOP
  • Time Frame: end of study
    

Secondary Measures

• Secondary endpoints are:IOP, safety
  • Time Frame: duration of study
    
• Mean reduction from baseline,
  • Time Frame: end of treatment periods
    
• Mean fluctuation of 24-hour IOP
  • Time Frame: end of treatment periods
    
• Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.
  • Time Frame: end of treatment periods
    

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 β-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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 29 Years

Maximum Age for this Clinical Trial: 81 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Aristotle University Of Thessaloniki

Overall Clinical Trial Officials and Contacts

Anastasios GP Konstas, MD, PhD Principal Investigator Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00444184

Study ID Number: A3243

ClinicalTrials.gov Identifier: NCT00444184

Health Authority: Greece: National Organization of Medicines