Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brinomidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil
This study has been terminated.
(Low recruitment rate)
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01514734
First received: January 18, 2012
Last updated: December 13, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma |
Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brinomidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Brazil |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Change in intra-ocular pressure (IOP) at 8 weeks from baseline (prior therapy). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Goldmann applanation tonometry will be performed at the baseline visit and at the 8-week visit to record IOP. Change at 8 weeks from baseline will be calculated. IOP will be measured in mmHg.
| Enrollment: | 9 |
| Study Start Date: | March 2012 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AZARGA
One drop self-administered in study eye(s) twice a day for 8 weeks
|
Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)
Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.
Other Name: AZARGA®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years of age or older.
- Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
- Be on a stable IOP (intra-ocular pressure) lowering regimen within 30 days of the Screening Visit.
- IOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period.
- Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
- IOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Presence of other primary or secondary glaucoma not listed in inclusion criteria #2.
- History of ocular herpes simplex.
- Abnormality preventing reliable applanation tonometry.
- Corneal dystrophies.
- Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
- Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening Visit.
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
- Progressive retinal or optic nerve disease from any cause.
- Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study.
- Pregnant or lactating.
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01514734 History of Changes |
| Other Study ID Numbers: | RDG-11-191 |
| Study First Received: | January 18, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Alcon Research:
|
Primary open-angle glaucoma Ocular hypertension Pigment dispersion glaucoma |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Timolol Maleic acid Brinzolamide Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Enzyme Inhibitors Carbonic Anhydrase Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013