Status:

COMPLETED

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

Lead Sponsor:

Aristotle University Of Thessaloniki

Collaborating Sponsors:

Alcon Research

Conditions:

Glaucoma

Eligibility:

All Genders

29-81 years

Phase:

PHASE4

Brief Summary

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 r...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2008

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT00444184

Start Date

March 1 2007

End Date

January 1 2008

Last Update

May 12 2014

Active Locations (1)

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Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, Greece, 546 36