A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01426867
First received: August 24, 2011
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Drug: Brinzolamide ophthalmic suspension, 1%
Drug: Brimonidine tartrate ophthalmic solution, 0.2%
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Descriptive Comfort Study of Brinzolamide 1% / Brimonidine Tartrate 0.2% Fixed Combination Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension and Brimonidine Tartrate 0.2% Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Ocular Discomfort Score [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).


Enrollment: 103
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brinz/Brim
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Active Comparator: Brinzolamide
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
Drug: Brinzolamide ophthalmic suspension, 1%
Active Comparator: Brimonidine
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
Drug: Brimonidine tartrate ophthalmic solution, 0.2%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sign Informed Consent document.
  • Diagnosis of open-angle glaucoma or ocular hypertension
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
  • Severe central vision loss in either eye.
  • Any chronic or recurrent inflammatory eye disease.
  • Ocular trauma within the preceding 6 months.
  • Ocular infection or ocular inflammation within the preceding 3 months.
  • Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
  • Any intraocular surgery within the preceding 6 months.
  • Any ocular laser surgery within the preceding 3 months.
  • History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426867

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Ravaughn Williams, OD, MS Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01426867     History of Changes
Other Study ID Numbers: C-11-002
Study First Received: August 24, 2011
Results First Received: May 17, 2013
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Alcon Research:
Open-Angle Glaucoma
Ocular Hypertension
Intraocular Pressure
Brinzolamide
Brimonidine

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Brimonidine
Brinzolamide
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014