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

A

Aristotle University Of Thessaloniki

Status and phase

Completed
Phase 4

Conditions

Glaucoma

Treatments

Drug: treatment with dorzolamide/timolol
Drug: treatment with brimonidine/timolol

Study type

Interventional

Funder types

Other

Identifiers

NCT00972257
A5132

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

29 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

64 participants in 2 patient groups

Drug: Dorzolamide/Timolol
Active Comparator group
Treatment:
Drug: treatment with dorzolamide/timolol
Treatment with Brimonidine/Timolol
Active Comparator group
Treatment:
Drug: treatment with brimonidine/timolol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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