Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Allergan

Status and phase: Withdrawn; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01284166

Dorzo-Brimo-Timo/2010

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Triple Combination Therapy

Experimental group

Description:

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.

Treatment:

Drug: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution