Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®

NCT02730871 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: GLJ576-P0012016-000176-20
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) dosed twice daily (BID) when added to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) in subjects with open-angle glaucoma or ocular hypertension.

Conditions

Open-angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6

  IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.

  Baseline, Week 6

Secondary Outcomes (4)

• Mean Diurnal IOP at Week 6

  Week 6

• Mean Percentage Change From Baseline in Diurnal IOP at Week 6

  Baseline, Week 6

• Mean Change From Baseline in IOP (09:00, 11:00) at Week 6

  Baseline, Week 6

• Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6

  Baseline, Week 6

Study Arms (2)

Simbrinza + Duotrav

EXPERIMENTAL

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension; Drug: Travoprost 0.004%/timolol 0.5% solution

Vehicle + Duotrav

PLACEBO COMPARATOR

Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

Drug: Brinzolamide/brimonidine vehicle; Drug: Travoprost 0.004%/timolol 0.5% solution

Interventions

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension DRUG

Also known as: SIMBRINZA® suspension

Simbrinza + Duotrav

Brinzolamide/brimonidine vehicle DRUG

Inactive ingredients used as placebo comparator

Vehicle + Duotrav

Travoprost 0.004%/timolol 0.5% solution DRUG

1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for up to 10 days during the Screening/Eligibility Phase and 42 days during the Treatment Phase

Also known as: DUOTRAV®

Simbrinza + Duotrav; Vehicle + Duotrav

Eligibility Criteria

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

You may qualify if:

• Diagnosis of open-angle glaucoma (including pseudoexfoliation or pigment dispersion glaucoma) or ocular hypertension.
• Currently on treatment with Travoprost 0.004%/Timolol 0.5% prescribed as approved in the country, on morning or evening dosing for at least 28 days prior to screening, and in the opinion of the Investigator may benefit from further IOP lowering.
• Mean IOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least 1 eye (the same eye(s) ≥ 19 and ≤ 28 mmHg at 09:00 while on a Travoprost 0.004%/ Timolol 0.5% solution.
• Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee.
• Willing and able to attend all study visits.

You may not qualify if:

• Women of childbearing potential: not postmenopausal for at least 1 year or less than 6 weeks since sterilization, currently pregnant; have a positive result on the urine pregnancy test at Screening; intend to become pregnant during the study period; breast-feeding; or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
• Mean IOP \> 28 mmHg at any time point in either eye during the Screening/Eligibility Phase.
• Any form of glaucoma other than open-angle glaucoma or ocular hypertension.
• Severe central visual field loss in either eye.
• Chronic, recurrent or severe inflammatory eye disease in either eye.
• Ocular trauma in either eye within the past 6 months prior to the Screening visit.
• Ocular infection or ocular inflammation in either eye within the past 3 months prior to the Screening visit.
• Retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
• Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye.
• Other ocular pathology (including severe dry eye) in either eye that may, in the opinion of the Investigator, preclude the safe administration of any study medication.
• Intraocular surgery in either eye within the past 6 months prior to the Screening visit.
• Ocular laser surgery in either eye within the past 3 months prior to the Screening visit.
• Any other condition including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study.
• Asthma, history of asthma, or severe chronic obstructive pulmonary disease.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon for Locations (Europe, Asia, and Latin America)

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

brinzolamide; Brimonidine Tartrate; Travoprost; Timolol; Solutions; Duotrav

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Morpholines; Oxazines; Pharmaceutical Preparations

Results Point of Contact

• Title: WW Brand Medical Director Ophtha, GMA Ophthalmics
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Assoc Global Trial Director, TM Ophtha

  Alcon Research

  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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 7, 2016
• Study Start: June 24, 2016
• Primary Completion: July 13, 2018
• Study Completion: July 13, 2018
• Last Updated: May 29, 2019
• Results First Posted: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)