Official Title: “24-Hour IOP Control With the Travoprost/Timolol Fixed Combination Compared With the Latanoprost/Timolol Fixed Combination, When Both Are Dosed in the Evening in Patients With Exfoliative Glaucoma”

A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.

Study Type: Interventional

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

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: treatment with latanoprost/timolol fixed combination
  • dosing in the evening with the two fixed combinations
• Drug: latanoprost/timolol fixed combination drops
  • once in the evening

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • treatment with travoprost/timolol fixed combination drops once in the evening
• Active Comparator: B
  • Treatment with latanoprost/timolol fixed combination

Primary Measures

• Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

• Incidence of side effects with the two medications
  • Time Frame: 3 months
    Safety Issue?: Yes

Inclusion Criteria:

• Patient has XFG and is older than 29 years
• The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)
• Patient can be safely washed out without risk for significant deterioration
• Distance best corrected Snelen visual acuity better than 0.1
• No contraindication to prostaglandins or β-blockers
• No history of lack of response (<10% reduction) to any medication
• Patient can understand the instructions and comply to medications
• Open normal appearing angles
• No sign of ocular infection, except blepharitis, corneal abnormality that may affect
• IOP measurements etc

Exclusion Criteria:

• History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
• Patient is a female of childbearing potential or lactating mother

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Aristotle University Of Thessaloniki

Overall Clinical Trial Officials and Contacts

Anastasios G Konstas, MD, PhD Principal Investigator Glaucoma Unit, 1st University Department of Ophthalmology  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00757835

Study ID Number: A6219

ClinicalTrials.gov Identifier: NCT00757835

Health Authority: Greece: National Organization of Medicines