Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Phase 3
Withdrawn
- Conditions
- GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT01284166
- Lead Sponsor
- Allergan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Triple Combination Therapy dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution 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.
- Primary Outcome Measures
Name Time Method Change from Baseline in Intraocular Pressure (IOP) Baseline, Week 12
- Secondary Outcome Measures
Name Time Method