Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Intraocular Pressure (IOP)-Lowering Efficacy and Safety of AZORGA® Ophthalmic Suspension and COSOPT® Ophthalmic Solution

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02325518
Recruitment Status : Completed
First Posted : December 25, 2014
Results First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Alcon, a Novartis Company )

Brief Summary:
The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension Drug: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution Drug: Subject's habitual PGA monotherapy Phase 4

Detailed Description:
After the screening examination, subjects were enrolled in the study and moved into the observation period. During the observation period, prostaglandin-analog (PGA) monotherapy was applied. After the observation period of 4 weeks or more, the baseline examination was performed. Subjects were then randomized and moved into the treatment period.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: The Efficacy and Safety of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 1%/Timolol 0.5% in Patients With Open-Angle Glaucoma and Ocular Hypertension
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: BRI/TIM
Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
Drug: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension
Other Name: AZORGA®

Drug: Subject's habitual PGA monotherapy
Active Comparator: DOR/TIM
Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
Drug: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution
Other Name: COSOPT®

Drug: Subject's habitual PGA monotherapy



Primary Outcome Measures :
  1. Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM [ Time Frame: Baseline (Day 0), Week 4, Week 8 at 11 AM ]
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 11 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.


Secondary Outcome Measures :
  1. Least Squares Mean Change From Baseline in IOP at 9 AM [ Time Frame: Baseline (Day 0), Week 4, Week 8 at 9 AM ]
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 9 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Understand the nature of the study and sign informed consent.
  • Diagnosis of open angle glaucoma or ocular hypertension.
  • Currently on PGA monotherapy or PGA + alpha-1/beta blocker or PGA + alpha-2 agonist at screening visit, and allowed to instill only PGA for 4 weeks until the baseline visit.
  • Intraocular pressure (IOP) ≥ 15 mmHg (at least one same eye) at the baseline visit.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • History of bronchial asthma, bronchospasm, or serious chronic obstruction pulmonary disease.
  • Uncontrolled heart failure, sinus bradycardia, A-V block (II, III grade), cardiogenic shock, right heart failure due to pulmonary hypertension or congestive heart failure.
  • History of hypersensitivity to any of the excipients of the study medications.
  • Severe renal function disorders, diabetic ketoacidosis and metabolic acidosis, uncontrolled diabetes, or hepatic disorders.
  • Corneal disorder or history of chronic, recurrent or current severe inflammatory eye disease in either eye.
  • History of ocular trauma in either eye within 6 months prior to the screening examination.
  • Ocular infection or ocular inflammation in either eye.
  • History of or current clinically significant or progressive retinal disease in either eye.
  • Intraocular surgery in either eye within 6 months prior to the screening examination.
  • Ocular laser surgery in either eye within 3 months prior to the screening examination.
  • Any abnormality preventing reliable applanation tonometry of either eye.
  • Best-corrected visual acuity (BCVA) worse than 0.2 score (decimal visual acuity) in either eye.
  • Severe visual field loss in either eye.
  • Use of prohibited medication, as specified in the protocol.
  • Pregnant, lactating, or intending to become pregnant during the study period.
  • Currently on therapy or have been on therapy with another investigational agent within 30 days prior to the screening examination.
  • History of or current evidence of a severe illness or any other condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
  • Other protocol-specified exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325518


Locations
Layout table for location information
Japan
Contact Alcon Japan Ltd. for Trial Locations
Tokyo, Japan, 107-0052
Sponsors and Collaborators
Alcon, a Novartis Company
Investigators
Layout table for investigator information
Study Director: Clinical and Regulatory Affairs Alcon Japan, Ltd.

Layout table for additonal information
Responsible Party: Alcon, a Novartis Company
ClinicalTrials.gov Identifier: NCT02325518     History of Changes
Other Study ID Numbers: ALJ-P2014-1
UMIN000017569 ( Registry Identifier: UMIN )
First Posted: December 25, 2014    Key Record Dates
Results First Posted: December 8, 2016
Last Update Posted: December 8, 2016
Last Verified: October 2016

Keywords provided by Alcon Research ( Alcon, a Novartis Company ):
Open-angle glaucoma (OAG)
Ocular hypertension (OHT)
AZORGA®
COSOPT®

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Dorzolamide
Maleic acid
Brinzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Carbonic Anhydrase Inhibitors