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OpenTrials
Completed

NCT Number: NCT00972257

24-hr Intraocular Pressure Control With Dorzolamide/Timolol vs the Brimonidine/Timolol Fixed Combination

The proposed study will compare for the first time the quality of 24-hour IOP control with Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may determine the real efficacy of the two fixed combinations and the design of the proposed study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less than might be anticipated.

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Key information

Conditions

Glaucoma Eye Diseases Glaucoma, Open-Angle Ocular Hypertension

Age range

29 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Glaucoma Unit, 1st University Dept of Ophthalmology

Thessaloniki, 546 36, Greece

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Consecutive, newly diagnosed or previously untreated POAG patients
  • Patients with typical glaucomatous disc, or visual field damage
  • Patient must have IOP (at 10:00 ± 1 hour)greater than 25 mm Hg

Exclusion criteria

  • Uncontrolled glaucoma
  • Distance best corrected Snellen visual acuity worse than 1/10
  • Contraindications to brimonidine or dorzolamide and β-blockers
  • History of lack of response (<10% morning IOP reduction) to any medication
  • Patient can not understand the instructions and adhere to medications
  • Patient is a female of childbearing potential or lactating mother
  • Prior surgery, past use of steroids (within 2 months)
  • Severe dry eyes and use of contact lenses
  • History of non-adherence
  • Patients with closed angles

Treatment and study plan

treatment with dorzolamide/timolol

Drug

24-hour IOP control with the two fixed combinations

treatment with brimonidine/timolol

Drug

24-hour pressure control with brimonidine/timolol

Primary outcomes

  1. To compare the quality of 24-hour IOP control after 2 months of chronic therapy with the Dorzolamide/Timolol fixed combination versus the Brimonidine/Timolol fixed combination in primary open-angle glaucoma.

    Time frame: 3 months

Secondary outcomes

  1. Assess fluctuation of 24-hour pressure

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Quality of 24-hour Intraocular Pressure Control Obtained With Dorzolamide/Timolol Fixed Combination (DTFC) Compared With the Brimonidine/Timolol Fixed Combination (BTFC) in Subjects With Primary Open-angle Glaucoma

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 4, 2009
Registry last updated
May 12, 2014

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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