Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00761995
First received: September 26, 2008
Last updated: July 17, 2012
Last verified: January 2012
  Purpose

Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: Azopt
Drug: Cosopt
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • IOP reduction from baseline at the end of 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • IOP reduction from baseline at the end of 4 and 8 weeks of treatment [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: February 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Azopt
topical eye drop dosed 1 drop 3 times daily
Drug: Azopt
topical eye drop dosed 1 drop 3 times daily
Other Name: Azopt
Active Comparator: Cosopt
topical eye drop
Drug: Cosopt
topical eye drop dosed 1 drop 2 times daily
Other Name: Cosopt

  Eligibility

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

Inclusion Criteria:

  • Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension.
  • If of child bearing potential

    * Must use a reliable means of contraception for the duration of the study or surgically sterilized.

  • Must have a negative pregnancy test.
  • Must be non-lactating
  • IOP measurements ≥ 24 ≤ 36 mm Hg, in at least one eye, at 9.00 a.m and ≥ 21 ≤ 36 mm Hg in at least one eye (the same eye) at 11.00 am measurement
  • The IOP criteria to be met at both time points by the same eye
  • Visual Acuity of 6/24 or better in study eye (s)
  • Gonioscopy angle of ≥ 2 in the study eye (s)
  • Patients with a level of understanding and willingness to fully comply with all visits and study procedures scheduled by the study site as evidenced by written informed consent

Exclusion Criteria:

  • Patients with one sighted eye or amblyopia
  • History of chronic or recurrent uveitis or other inflammatory eye disease (e.g. scleritis).
  • History of ocular infections (e.g. conjunctivitis) within past 3 months.
  • History of ocular trauma within the past 6 months.
  • History of severe or progressive retinal (i.e. retinal degeneration, diabetic retinopathy, retinal detachment or retinal tears) or optic nerve disease.
  • History of severe ocular pathology such as severe glaucoma damage determined by optic nerve head (e.g. C/D ratio > 0.8) or visual field evaluation (e.g. split fixation, clinically significant field loss within the central field) or legal blindness in either eye.
  • Intraocular surgery within the past 12 months or Laser surgery within the past 3 months as determined by patient history and/or examination.
  • Any other form of glaucoma other than primary open angle glaucoma.
  • Inability to discontinue contact lens wear during the day
  • History of hypersensitivity to oral or topical CAIs, sulfonamide drugs or to any component of these medicines.
  • Any abnormality preventing reliable applanation tonometry of either eye.
  • Patients who are in the investigator's best judgement at risk of visual field or visual acuity worsening as a consequence of participation of trial.
  • Chronic use of any systemic medication that may effect IOP with less than one month stable dosing regimen (i.e. sympathomimetic agents, beta-adrenergic blocking agents, alpha agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.).
  • Current use of any ophthalmic, dermatologic or systemic steroid.
  • Patients with clinically significant medical (acute or progressive) condition e.g. cardiovascular, pulmonary, hematologic disease or psychiatric illness, who are unlikely to fully complete all protocol requirements as assessed by the investigator.
  • Participation in another clinical trial within past 30 days.
  • Pregnant and lactating females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761995

Locations
India
Alcon Laboratories, India
Bangalore, India, 560016
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00761995     History of Changes
Other Study ID Numbers: MA-CT-08-003
Study First Received: September 26, 2008
Last Updated: July 17, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Alcon Research:
Raised IOP

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Ophthalmic Solutions
Brinzolamide
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014