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

• ClinicalTrials.gov Identifier: NCT02419508
• Recruitment Status: Completed
• First Posted: April 17, 2015
• Results First Posted: November 15, 2018
• Last Update Posted: November 15, 2018
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Open-Angle Glaucoma; Ocular Hypertension	Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension; Drug: Brinz/brim vehicle; Drug: Prostaglandin analogue	Phase 4

Detailed Description:

This study consisted of 2 sequential phases: Screening/Eligibility Phase, followed by a Masked Treatment Phase (Phase II). Subjects were assigned into one of 3 PGA therapy groups for the duration of the study, based upon commercial availability.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 290 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue
• Actual Study Start Date: August 7, 2015
• Actual Primary Completion Date: February 27, 2018
• Actual Study Completion Date: February 27, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: SIMBRINZA + PGA; 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; Other Name: SIMBRINZA® suspension; Drug: Prostaglandin analogue; Other Names: TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%); LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%); XALATAN® (Latanoprost ophthalmic solution, 0.005%)
Vehicle + PGA; 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; Inactive ingredients used as a placebo for masking purposes; Drug: Prostaglandin analogue; Other Names: TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%); LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%); XALATAN® (Latanoprost ophthalmic solution, 0.005%)

Outcome Measures

Primary Outcome Measures :

1. Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6 [ Time Frame: Baseline, 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.

Secondary Outcome Measures :

1. Mean Diurnal IOP at Week 6 [ Time Frame: 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 higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.
2. Mean Percentage Change From Baseline in Diurnal IOP at Week 6 [ Time Frame: Baseline, 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 percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
3. Mean Change From Baseline in IOP at 11:00 at Week 6 [ Time Frame: Baseline, Week 6 ]
   IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
4. Mean Percentage Change From Baseline in IOP at 11:00 at Week 6 [ Time Frame: Baseline, Week 6 ]
   IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
5. Mean Change From Baseline in IOP at 09:00 at Week 6 [ Time Frame: Baseline, Week 6 ]
   IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 09:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
6. Mean Percentage Change From Baseline at 09:00 at Week 6 [ Time Frame: Baseline, Week 6 ]
   IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 9:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits.A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• 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;
• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

United States, Texas

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Clinical Manager, Ophtha, GCRA; Alcon, a Novartis Company

  Study Documents (Full-Text)

Documents provided by Alcon Research:

Statistical Analysis Plan  [PDF] March 12, 2018

Study Protocol  [PDF] March 30, 2017

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02419508
• Other Study ID Numbers: GLH694-P001; 2015-000736-15 ( EudraCT Number ); REec-2015-1723 ( Registry Identifier: Registro Espanol de Estudios Clinicos )
• First Posted: April 17, 2015
• Results First Posted: November 15, 2018
• Last Update Posted: November 15, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma; Eye Diseases; Brimonidine Tartrate; Bimatoprost; Travoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions; Brinzolamide; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Carbonic Anhydrase Inhibitors; Enzyme Inhibitors