Clinical trial NCT00761995: Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Keywords: Raised IOP
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: IOP reduction from baseline at the end of 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: IOP reduction from baseline at the end of 4 and 8 weeks of treatment
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Alcon Laboratories, India
Study officials:
References: