24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG
Phase 4
Completed
- Conditions
- Glaucoma
- Interventions
- Drug: treatment with latanoprost/timolol fixed combinationDrug: latanoprost/timolol fixed combination drops
- Registration Number
- NCT00757835
- Lead Sponsor
- Aristotle University Of Thessaloniki
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Travoprost/timolol therapy latanoprost/timolol fixed combination drops treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring. Latanoprost/timolol therapy latanoprost/timolol fixed combination drops Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring. Travoprost/timolol therapy treatment with latanoprost/timolol fixed combination treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring. Latanoprost/timolol therapy treatment with latanoprost/timolol fixed combination Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring.
- Primary Outcome Measures
Name Time Method Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol 3 months
- Secondary Outcome Measures
Name Time Method Incidence of side effects with the two medications 3 months