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Completed

NCT Number: NCT00444184

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

29 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, 546 36, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Travoprost/timolol fixed combination, travoprost

Drug

Primary outcomes

  1. Mean 24-hour IOP

    Time frame: 3 months

Secondary outcomes

  1. Mean reduction from baseline

    Time frame: 3 months

  2. Mean fluctuation of 24-hour IOP

    Time frame: 3 months

  3. Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Alcon Research

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 7, 2007
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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