Overview

24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborator:
Alcon Research
Treatments:
Latanoprost
Timolol
Travoprost
Criteria
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