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Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
This study has been withdrawn prior to enrollment.
(Study was never initiated due to company decision. No study subjects were ever enrolled or treated.)
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01284166
First received: January 25, 2011
Last updated: July 17, 2013
Last verified: July 2013
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Purpose
This study will investigate the safety and efficacy of Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution in patients with glaucoma or ocular hypertension who have elevated IOP on dorzolamide hydrochloride/timolol maleate combination therapy.
| Condition | Intervention | Phase |
|---|---|---|
| Glaucoma Ocular Hypertension | Drug: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
Drug Information available for:
Timolol
Timolol maleate
Brimonidine tartrate
Dorzolamide
Dorzolamide hydrochloride
U.S. FDA Resources
Further study details as provided by Allergan:
Primary Outcome Measures:
- Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 12 ]
| Enrollment: | 0 |
| Study Start Date: | July 2013 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Triple Combination Therapy
Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
|
Drug: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution
1 drop of Triple Combination Therapy (dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution) administered to each eye, twice daily for 12 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of ocular hypertension or glaucoma in each eye
- Requires IOP-lowering treatment in both eyes
Exclusion Criteria:
- Use of dorzolamide or carbonic anhydrase within 4 weeks
- Any other active ocular disease other than ocular hypertension or glaucoma (eg, uveitis, ocular infections or severe dry eye)
- Required chronic use of ocular medications other than study medication during the study (intermittent use of certain products eg, artificial tears are permitted)
- Use of oral, injectable or topical ophthalmic steroids within 21 days
- Any eye laser surgery within 3 months
- Any intraocular surgery (eg cataract surgery) within 6 months
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284166
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284166
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
More Information
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01284166 History of Changes |
| Other Study ID Numbers: |
Dorzo-Brimo-Timo/2010 |
| Study First Received: | January 25, 2011 |
| Last Updated: | July 17, 2013 |
Additional relevant MeSH terms:
|
Hypertension Glaucoma Ocular Hypertension Vascular Diseases Cardiovascular Diseases Eye Diseases Pharmaceutical Solutions Ophthalmic Solutions Timolol Dorzolamide Brimonidine Tartrate Adrenergic beta-Antagonists |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Carbonic Anhydrase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 21, 2017