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CompletedNCT00444184Updated May 12, 2014

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

A Phase 4 interventional study of Travoprost/timolol fixed combination, travoprost in Glaucoma, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 29 Years to 81 Years. Per ClinicalTrials.gov, last updated 2014-05-12.

Sponsored by Aristotle University Of Thessaloniki · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
29 Years to 81 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Glaucoma

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Keywords

  • travoprost/timolol fixed combination
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 32 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Years to 81 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    Travoprost/Timolol therapy

    24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops

    Drug: Travoprost/timolol fixed combination, travoprost

  • Active comparator
    Travoprost therapy

    24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops

    Drug: Travoprost/timolol fixed combination, travoprost

Interventions

  • DrugTravoprost/timolol fixed combination, travoprost
06

What researchers measure

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

07

Study locations

1 site
  • Glaucoma Unit, 1st University Department of Ophthalmology
    Thessaloniki, 546 36, Greece
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00444184
Lead sponsor
Aristotle University Of Thessaloniki
Collaborators
Alcon Research
Responsible party
AGP Konstas (Professor in Ophthalmology, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Mar 7, 2007
Start date
Mar 2007
Primary completion
Jan 2008
Completion
Jan 2008
Last update
May 12, 2014

Study contacts

Anastasios GP Konstas, MD, PhD
principal investigator · Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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