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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01284166

Enrollment

Registered

2011-01-26

Start date

2013-07-31

Completion date

2014-05-31

Last updated

2013-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension

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.

Interventions

DRUGdorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution

1 drop of Triple Combination Therapy (dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution) administered to each eye, twice daily for 12 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change from Baseline in Intraocular Pressure (IOP)	Baseline, Week 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026