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

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Completed
CT.gov ID
NCT00444184
Collaborator
Alcon Research (Industry)
32
Enrollment
1
Location
2
Arms
10.1
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Travoprost/timolol fixed combination, travoprost
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official 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
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Mean 24-hour IOP [3 months]

Secondary Outcome Measures

  1. Mean reduction from baseline [3 months]

  2. Mean fluctuation of 24-hour IOP [3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
29 Years to 81 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Glaucoma Unit, 1st University Department of Ophthalmology Thessaloniki Greece 546 36

Sponsors and Collaborators

  • Aristotle University Of Thessaloniki
  • Alcon Research

Investigators

  • Principal Investigator: Anastasios GP Konstas, MD, PhD, Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00444184
Other Study ID Numbers:
  • A3243
First Posted:
Mar 7, 2007
Last Update Posted:
May 12, 2014
Last Verified:
May 1, 2014
Keywords provided by AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
travoprost/timolol fixed combination
Additional relevant MeSH terms:
Glaucoma
Timolol
Travoprost

Study Results

No Results Posted as of May 12, 2014