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

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00444184
First received: March 5, 2007
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Mean 24-hour IOP [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean reduction from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Mean fluctuation of 24-hour IOP [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   29 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444184

Locations
Greece
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
  More Information

No publications provided

Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00444184     History of Changes
Other Study ID Numbers: A3243
Study First Received: March 5, 2007
Last Updated: January 25, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:
travoprost/timolol fixed combination

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Travoprost
Cloprostenol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on June 17, 2013