Full Text View
Tabular View
No Study Results Posted
Related Studies
24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG
This study has been completed.
Study NCT00757835   Information provided by Aristotle University Of Thessaloniki
First Received: September 19, 2008   Last Updated: September 16, 2009   History of Changes

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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP