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24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00981786
First received: September 16, 2009
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

The proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. This comparison may determine the real efficacy of the two fixed combinations when added to the prostaglandin. The design of the proposed study should facilitate a better understanding of the role of these medications in glaucoma management.


Condition Intervention Phase
Glaucoma
 Drug: Brimonidine/timolol fixed combination drops added to travoprost
Drug: Brinzolamide/timolol fixed combination drops added to 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: Quality of 24-hour Intraocular Pressure Control Obtained With the Brinzolamide/Timolol Fixed Combination Compared With the Brimonidine/Timolol Fixed Combination When Added to Travoprost Monotherapy in Subjects With 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 intraocular pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fluctuation of 24-hour intraocular pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brinzolamide/Timolol therapy
Chronic therapy for 3 months with brinzolamide/timolol drops given twice daily added to travoprost drops
 Drug: Brimonidine/timolol fixed combination drops added to travoprost
twice daily administration
Other Name: Combigan
Drug: Brinzolamide/timolol fixed combination drops added to travoprost
twice daily dosing
Other Name: Azarga
Active Comparator: Brimonidine/Timolol therapy
Chronic therapy for 3 months with brimonidine/timolol drops given twice daily added to travoprost drops
 Drug: Brimonidine/timolol fixed combination drops added to travoprost
twice daily administration
Other Name: Combigan
Drug: Brinzolamide/timolol fixed combination drops added to travoprost
twice daily dosing
Other Name: Azarga

  Eligibility

Ages Eligible for Study:   29 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has open-angle glaucoma and is older than 29 years
  • Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg
  • Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction
  • Patient deemed by PI to require adjunctive therapy to obtain desired target IOP
  • Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00)
  • Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less)
  • Distance best corrected Snellen visual acuity at least 0.1
  • No contraindications to travoprost, brimonidine, brinzolamide and β-blockers
  • No history of lack of response (<10% morning IOP reduction) to any medication
  • Patient can understand the instructions and adhere to medications

Exclusion Criteria:

  • Female patient of childbearing potential or lactating mother
  • History of trauma, inflammation, surgery
  • History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses
  • Signs of ocular infection, except blepharitis
  • Evidence of corneal abnormality that may affect IOP measurements etc
  • Closed angle
  • History of non-compliance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981786

Sponsors and Collaborators
Aristotle University Of Thessaloniki
Alcon Research
Investigators
Principal Investigator: Anastasios G Konstas, MD, PhD 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: NCT00981786     History of Changes
Other Study ID Numbers: A434
Study First Received: September 16, 2009
Last Updated: January 25, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:
24-hour IOP control
brinzolamide/timolol
brimonidine/timolol
travoprost

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Timolol
Brimonidine
Travoprost
Brinzolamide
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
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013