SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)

NCT02419508 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: GLH694-P0012015-000736-15REec-2015-1723
• Study Type: interventional
• Target: 290
• 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% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

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

  IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

  Baseline, Week 6

Secondary Outcomes (6)

• 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 at 11:00 at Week 6

  Baseline, Week 6

• Mean Percentage Change From Baseline in IOP at 11:00 at Week 6

  Baseline, Week 6

• Mean Change From Baseline in IOP at 09:00 at Week 6

  Baseline, Week 6

Study Arms (2)

SIMBRINZA + PGA

EXPERIMENTAL

Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days

Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension; Drug: Prostaglandin analogue

Vehicle + PGA

OTHER

Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days

Drug: Brinz/brim vehicle; Drug: Prostaglandin analogue

Interventions

Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension DRUG

Also known as: SIMBRINZA® suspension

SIMBRINZA + PGA

Brinz/brim vehicle DRUG

Inactive ingredients used as a placebo for masking purposes

Vehicle + PGA

Prostaglandin analogue DRUG

Also known as: TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%), LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%), XALATAN® (Latanoprost ophthalmic solution, 0.005%)

SIMBRINZA + PGA; Vehicle + PGA

Eligibility Criteria

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

You may qualify if:

• Diagnosis of either open-angle glaucoma or ocular hypertension;
• Must sign an informed consent form;
• Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye\[s\]) ≥ 19 and \< 32 mmHg at 09:00.
• Willing and able to attend all study visits;

You may not qualify if:

• Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;
• Any form of glaucoma other than open-angle glaucoma or ocular hypertension;
• Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;
• Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

brinzolamide; Brimonidine Tartrate; Prostaglandins, Synthetic; Bimatoprost; Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic

Results Point of Contact

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

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, Ophtha, GCRA

  Alcon, a Novartis Company

  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: April 14, 2015
• First Posted: April 17, 2015
• Study Start: August 7, 2015
• Primary Completion: February 27, 2018
• Study Completion: February 27, 2018
• Last Updated: November 15, 2018
• Results First Posted: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)