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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761995
• Other study ID #: MA-CT-08-003
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2008
• Last updated: July 17, 2012
• Start date: February 2009
• Est. completion date: July 2010

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

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

Locations

Country	Name	City	State
India	Alcon Laboratories, India	Bangalore

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP reduction from baseline at the end of 12 weeks		12 weeks	Yes
Secondary	IOP reduction from baseline at the end of 4 and 8 weeks of treatment		4 and 8 weeks	Yes