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

NCT00761995 | Completed Phase 4

• 1 other identifier: MA-CT-08-003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma; Ocular Hypertension

Keywords

Raised IOP

Outcome Measures

Primary Outcomes (1)

• IOP reduction from baseline at the end of 12 weeks

  12 weeks

Secondary Outcomes (1)

• IOP reduction from baseline at the end of 4 and 8 weeks of treatment

  4 and 8 weeks

Study Arms (2)

Azopt

ACTIVE COMPARATOR

topical eye drop dosed 1 drop 3 times daily

Drug: Azopt

Cosopt

ACTIVE COMPARATOR

topical eye drop

Drug: Cosopt

Interventions

Azopt DRUG

topical eye drop dosed 1 drop 3 times daily

Azopt

Cosopt DRUG

topical eye drop dosed 1 drop 2 times daily

Cosopt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Laboratories, India

Bangalore, 560016, India

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

brinzolamide; dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: February 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 18, 2012

Record last verified: 2012-01

Locations

IN (1)