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

Ocular Hypertension Clinical Trial

Official title:

Safety and Efficacy With Twice Daily Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) as an Adjunctive Therapy to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02730871
• Other study ID #: GLJ576-P001
• Secondary ID: 2016-000176-20
• Status: Terminated
• Phase: Phase 4
• Start date: June 24, 2016
• Est. completion date: July 13, 2018

Study information

• Verified date: May 2019
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is divided into 2 sequential phases for a total of 5 visits. Phase I of the study is the open-labeled Screening/Eligibility Phase, which includes a Screening Visit followed by 2 Eligibility Visits. Phase II of the study is the randomized, double-masked Treatment Phase, which includes 2 on-therapy visits: Visit 4 (at Week 2) and Visit 5 (Week 6, Exit Visit).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 173
• Est. completion date: July 13, 2018
• Est. primary completion date: July 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Drug:
• Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension

• Brinzolamide/brimonidine vehicle
Inactive ingredients used as placebo comparator
• 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 up to 10 days during the Screening/Eligibility Phase and 42 days during the Treatment Phase

Locations

Country	Name	City	State
United States	Contact Alcon for Locations (Europe, Asia, and Latin America)	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Diurnal IOP at Week 6	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP was defined as the average of the two time points measured (9 AM, 11 AM). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was used for the analyses.	Week 6
Secondary	Mean Percentage Change From Baseline in Diurnal IOP at Week 6	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP percentage change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative percentage 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	Mean Change From Baseline in IOP (09:00, 11:00) at Week 6	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. 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	Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative percentage 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

External Links

•   Results from the Novartis Clinical Trial Results Website