Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Open-Angle Glaucoma; Ocular Hypertension
Intervention: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension (Drug); Brinzolamide ophthalmic suspension, 1% (Drug); Brimonidine tartrate ophthalmic solution, 0.2% (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s): James Teague, BS, Sr. Clinical Manager, Study Director, Affiliation: Alcon Research
Summary
The purpose of this study was to evaluate the efficacy and safety of a fixed combination of
Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its
individual active components in patients with open-angle glaucoma and/or ocular
hypertension.
Clinical Details
Official title: Three Month Efficacy and Safety Study of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Three Times Daily in Patients With Open-Angle Glaucoma and/or Ocular Hypertension
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)
Detailed description:
This study consisted of 6 visits conducted during 2 sequential phases: the
Screening/Eligibility phase, which included a screening visit and 2 eligibility visits, and
the Treatment phase, which included 3 on-therapy visits conducted at Week 2, Week 6, and
Month 3. A washout period based on previous ocular medication preceded Eligibility Visit 1.
Patients who met all inclusion/exclusion criteria at both eligibility visits were randomized
(1: 1:1) to receive treatment with 1 of 3 study drugs for 3 months. Study drug instillation
began the morning after the second eligibility visit.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Sign Informed Consent document.
- Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular
pressure within protocol-specified range at eligibility visit/s.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Females of childbearing potential if pregnant, lactating, or not using highly
effective birth control measures.
- Any form of glaucoma other than open-angle glaucoma.
- Severe central vision loss in either eye.
- Chronic, recurrent, or severe inflammatory eye disease.
- Ocular trauma within the preceding 6 months.
- Ocular infection or ocular inflammation within the preceding 3 months.
- Clinically significant or progressive retinal disease such as retinal degeneration,
diabetic retinopathy, or retinal detachment.
- Best-corrected visual acuity score worse than 55 letters using the Early Treatment
Diabetic Retinopathy Study chart.
- Other ocular pathology (including severe dry eye) that may, in the opinion of the
Investigator, preclude the administration of study product.
- Ocular surgery within the preceding 6 months.
- Ocular laser surgery within the preceding 3 months.
- Any abnormality preventing reliable applanation tonometry.
- Any other conditions, including severe illness, which could make the patient, in the
opinion of the Investigator, unsuitable for the study.
- Other protocol-specified exclusion criteria may apply.
Locations and Contacts
Additional Information
Starting date: February 2011
Last updated: May 14, 2013
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