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OpenTrials
Completed

NCT Number: NCT00981786

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

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.

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Key information

Age range

29 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brimonidine/timolol fixed combination drops added to travoprost

Drug

twice daily administration

Other names: Combigan

Brinzolamide/timolol fixed combination drops added to travoprost

Drug

twice daily dosing

Other names: Azarga

Primary outcomes

  1. Mean 24-hour intraocular pressure

    Time frame: 3 months

Secondary outcomes

  1. Fluctuation of 24-hour intraocular pressure

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Alcon Research

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 22, 2009
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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