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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01284166
• Other study ID #: Dorzo-Brimo-Timo/2010
• Status: Withdrawn
• Phase: Phase 3
• First received: January 25, 2011
• Last updated: July 17, 2013
• Start date: July 2013
• Est. completion date: May 2014

Study information

• Verified date: July 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• dorzolamide 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Intraocular Pressure (IOP)		Baseline, Week 12	No