Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01297517
First received: February 15, 2011
Last updated: March 27, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Open-Angle Glaucoma Ocular Hypertension |
Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension Drug: Brinzolamide ophthalmic suspension, 1% Drug: Brimonidine tartrate ophthalmic solution, 0.2% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h) [ Time Frame: Month 3 ] [ Designated as safety issue: No ]At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. Intraocular pressure was measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
| Enrollment: | 1001 |
| Study Start Date: | February 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Brinzolamide/Brimonidine
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day for 3 months
|
Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension |
|
Active Comparator: Brinzolamide
Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day for 3 months
|
Drug: Brinzolamide ophthalmic suspension, 1%
Other Name: AZOPT®
|
|
Active Comparator: Brimonidine
Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day for 3 months
|
Drug: Brimonidine tartrate ophthalmic solution, 0.2% |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01297517 History of Changes |
| Other Study ID Numbers: | C-10-033 |
| Study First Received: | February 15, 2011 |
| Results First Received: | March 27, 2013 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Alcon Research:
|
AOG OHT Open-Angle Glaucoma Ocular Hypertension |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Brimonidine Brinzolamide Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Carbonic Anhydrase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013