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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 February 2013 |
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Main ID: |
NCT01284166 |
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Date of registration:
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25/01/2011 |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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Date of first enrolment:
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July 2013 |
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Target sample size:
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120 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01284166 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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India
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Contacts
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Name:
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Allergan Inc. |
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Address:
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Telephone:
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Email:
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clinicaltrials@allergan.com |
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Affiliation:
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allergan |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Glaucoma
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Ocular Hypertension
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Intervention(s)
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Drug: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution
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Primary Outcome(s)
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Change from Baseline in Intraocular Pressure (IOP)
[Time Frame: Baseline, Week 12]
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Secondary ID(s)
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Dorzo-Brimo-Timo/2010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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