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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2009

Intervention(s) in this Clinical Trial

• Drug: Azopt
  • topical eye drop dosed 1 drop 3 times daily
• Drug: Cosopt
  • topical eye drop dosed 1 drop 2 times daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • topical eye drop dosed 1 drop 3 times daily
• Active Comparator: 2
  • topical eye drop

Primary Measures

• IOP reduction from baseline at the end of 12 weeks
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Secondary Measures

• IOP reduction from baseline at the end of 4 and 8 weeks of treatment
  • Time Frame: 4 and 8 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Alcon Research

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00761995

Study ID Number: MA-CT-08-003

ClinicalTrials.gov Identifier: NCT00761995

Health Authority: India: Institutional Review Board