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

NCT01284166 | Withdrawn Phase 3

• 1 other identifier: Dorzo-Brimo-Timo/2010
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Intraocular Pressure (IOP)

  Baseline, Week 12

Study Arms (1)

Triple Combination Therapy

EXPERIMENTAL

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.

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

Interventions

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

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.

Triple Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ocular hypertension or glaucoma in each eye
• Requires IOP-lowering treatment in both eyes

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

dorzolamide; Brimonidine Tartrate; Timolol; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 26, 2011
• Study Start: July 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 18, 2013

Record last verified: 2013-07