| September 19, 2008 |
| September 16, 2009 |
| May 2008 |
| March 2009 (final data collection date for primary outcome measure) |
| Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol [ Time Frame: 3 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00757835 on ClinicalTrials.gov Archive Site |
| Incidence of side effects with the two medications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| 24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG |
| 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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study |
| Glaucoma |
- Drug: treatment with latanoprost/timolol fixed combination
- Drug: latanoprost/timolol fixed combination drops
|
- Active Comparator: treatment with travoprost/timolol fixed combination drops once in the evening
- Active Comparator: Treatment with latanoprost/timolol fixed combination
|
| |
| |
| Completed |
| 40 |
| March 2009 |
| March 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 21 Years to 85 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00757835 |
| Associate Professor AGP Konstas, Glaucoma Unit, 1st University Department of Ophthalmology |
| A6219 |
| Aristotle University Of Thessaloniki |
| Alcon Research |
| Principal Investigator: |
Anastasios G Konstas, MD, PhD |
Glaucoma Unit, 1st University Department of Ophthalmology |
|
|
| Aristotle University Of Thessaloniki |
| September 2009 |