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Withdrawn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: Glaucoma; Ocular Hypertension
• Interventions: Drug: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution

• 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

Study Timeline

• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Status Verified: 2013-07
• Study Start: 2013-07
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-18
• Primary Completion: 2014-05
• Study Completion: 2014-05

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• Status: WITHDRAWN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