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

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. Identifier: NCT00444184
Recruitment Status : Completed
First Posted : March 7, 2007
Last Update Posted : May 12, 2014
Alcon Research
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki

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
Glaucoma Drug: Travoprost/timolol fixed combination, travoprost Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : March 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

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

Primary Outcome Measures :
  1. Mean 24-hour IOP [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   29 Years to 81 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00444184

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Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, Greece, 546 36
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Alcon Research
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Principal Investigator: Anastasios GP Konstas, MD, PhD Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology
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Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki Identifier: NCT00444184    
Other Study ID Numbers: A3243
First Posted: March 7, 2007    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014
Keywords provided by AGP Konstas, Aristotle University Of Thessaloniki:
travoprost/timolol fixed combination
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents