Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Summary
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.
Clinical Details
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from Baseline in Intraocular Pressure (IOP)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: July 2013
Last updated: July 17, 2013
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