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Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)

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Alcon

Status and phase

Terminated
Phase 4

Conditions

Intraocular Pressure

Treatments

Drug: Travoprost 0.004% + Brinzolamide 1.0%
Drug: Travoprost 0.004% + Tears Natural

Study type

Interventional

Funder types

Industry

Identifiers

NCT00758342
MS-06-01

Details and patient eligibility

About

To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 18 years;
  • CACG (Chronic Angle Closure Glaucoma) ≥ 1eye
  • have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes
  • clinical stability of VA (Visual Acuity) and optic nerve throughout the study

Exclusion criteria

  • Abnormality restricts exam of the fundus or anderior chamber
  • conjunctivitis, keratitis or uveitis
  • unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks
  • ocular surgery prior to the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

37 participants in 2 patient groups

Travoprost 0.004% + Brinzolamide 1.0%
Experimental group
Description:
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Treatment:
Drug: Travoprost 0.004% + Brinzolamide 1.0%
Travoprost 0.004% + Tears Natural
Active Comparator group
Description:
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
Treatment:
Drug: Travoprost 0.004% + Tears Natural

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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