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24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00444184
First Posted: March 7, 2007
Last Update Posted: May 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alcon Research
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
March 5, 2007
March 7, 2007
May 12, 2014
March 2007
January 2008   (Final data collection date for primary outcome measure)
Mean 24-hour IOP [ Time Frame: 3 months ]
The primary endpoint is mean 24-hour IOP.
Complete list of historical versions of study NCT00444184 on ClinicalTrials.gov Archive Site
  • Mean reduction from baseline [ Time Frame: 3 months ]
  • Mean fluctuation of 24-hour IOP [ Time Frame: 3 months ]
  • Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours. [ Time Frame: 3 months ]
  • Secondary endpoints are:
  • Mean reduction from baseline,
  • Mean fluctuation of 24-hour IOP
  • Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.
  • Safety endpoints will include visual acuity, adverse events, slit lamp biomicroscopy and optic nerve assessment.
Not Provided
Not Provided
 
24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost
A Crossover, Double-Masked Comparison Investigating the 24-Hour Intraocular Pressure Control With the Travoprost/Timolol Fixed Combination Versus Travoprost, When Both Are Given in the Evening, in Subjects With Primary Open-Angle Glaucoma
This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Glaucoma
Drug: Travoprost/timolol fixed combination, travoprost
  • Active Comparator: Travoprost/Timolol therapy
    24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops
    Intervention: Drug: Travoprost/timolol fixed combination, travoprost
  • Active Comparator: Travoprost therapy
    24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops
    Intervention: Drug: Travoprost/timolol fixed combination, travoprost
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2008
January 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00).
  • Patient has POAG and is older than 29 years
  • The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00)
  • Patient can be safely washed out without risk for significant deterioration
  • Distance best corrected Snellen visual acuity better than 1/10
  • Patient can understand the instructions and comply to medications
  • Open normal appearing angles

Exclusion Criteria:

  • Contraindications to prostaglandins or β-blockers
  • History of lack of response (<10% reduction) to any medication
  • Female of childbearing potential or lactating mother
  • History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
  • Sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc
Sexes Eligible for Study: All
29 Years to 81 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT00444184
A3243
No
Not Provided
Not Provided
AGP Konstas, Aristotle University Of Thessaloniki
Aristotle University Of Thessaloniki
Alcon Research
Principal Investigator: Anastasios GP Konstas, MD, PhD Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology
Aristotle University Of Thessaloniki
May 2014

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