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

Alcon

Status and phase: Terminated; Phase 4

Conditions: Open-angle Glaucoma; Ocular Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02730871

GLJ576-P001

2016-000176-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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173 participants in 2 patient groups, including a placebo group

Simbrinza + Duotrav

Experimental group

Description:

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)

Treatment:

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

Drug: Travoprost 0.004%/timolol 0.5% solution

Vehicle + Duotrav

Placebo Comparator group

Description:

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)

Treatment:

Drug: Travoprost 0.004%/timolol 0.5% solution

Drug: Brinzolamide/brimonidine vehicle