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

This study has been terminated.
(difficulty of enrolling patients)
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00758342
First received: September 23, 2008
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Intraocular Pressure
Drug: Travoprost 0.004% + Brinzolamide 1.0%
Drug: Travoprost 0.004% + Tears Natural
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% (AZOPT) as Adjunctive Therapy to Travoprost 0.004% (TRAVATAN) in Patients With Chronic Angle-Closure Glaucoma

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean IOP (Intraocular Pressure) [ Time Frame: Screening: Week 12; (At 9 am and 4 pm time points) ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: May 2006
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Travoprost 0.004% + Brinzolamide 1.0%
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Drug: Travoprost 0.004% + Brinzolamide 1.0%
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Active Comparator: Travoprost 0.004% + Tears Natural
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
Drug: Travoprost 0.004% + Tears Natural
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758342

Locations
United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Benny Li, Regional Scientific Clinical Affaires Manager, Alcon Research
ClinicalTrials.gov Identifier: NCT00758342     History of Changes
Other Study ID Numbers: MS-06-01
Study First Received: September 23, 2008
Results First Received: September 10, 2009
Last Updated: February 23, 2010
Health Authority: China: Ethics Committee

Keywords provided by Alcon Research:
IOP lowering efficacy and safety of Azopt plus Travatan

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases
Brinzolamide
Travoprost
Cloprostenol
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014