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

NCT02325518 | Completed Phase 4 Results

• 2 other identifiers: ALJ-P2014-1UMIN000017569
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

Open-angle glaucoma (OAG); Ocular hypertension (OHT); AZORGA®; COSOPT®

Outcome Measures

Primary Outcomes (1)

• Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) 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.

  Baseline (Day 0), Week 4, Week 8 at 11 AM

Secondary Outcomes (1)

• Least Squares Mean Change From Baseline in IOP at 9 AM

  Baseline (Day 0), Week 4, Week 8 at 9 AM

Study Arms (2)

BRI/TIM

EXPERIMENTAL

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; Drug: Subject's habitual PGA monotherapy

DOR/TIM

ACTIVE COMPARATOR

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; Drug: Subject's habitual PGA monotherapy

Interventions

Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension DRUG

Also known as: AZORGA®

BRI/TIM

Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution DRUG

Also known as: COSOPT®

DOR/TIM

Subject's habitual PGA monotherapy DRUG

BRI/TIM; DOR/TIM

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon, a Novartis Company: lead

Study Sites (1)

Contact Alcon Japan Ltd. for Trial Locations

Tokyo, 107-0052, Japan

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

brinzolamide; Timolol; dorzolamide; Ophthalmic Solutions; dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Novartis Pharma KK
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical and Regulatory Affairs

  Alcon Japan, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 25, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 8, 2016
• Results First Posted: December 8, 2016

Record last verified: 2016-10

Locations

JP (1)