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

NCT ID: NCT02730871

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-24
• Study Completion Date: 2018-07-13

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.

Detailed 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).

Conditions

Open-angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Simbrinza + Duotrav

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)

Group Type: EXPERIMENTAL

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension

Intervention Type: DRUG

Travoprost 0.004%/timolol 0.5% solution

Intervention Type: 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

Vehicle + Duotrav

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)

Group Type: PLACEBO_COMPARATOR

Brinzolamide/brimonidine vehicle

Intervention Type: DRUG

Inactive ingredients used as placebo comparator

Travoprost 0.004%/timolol 0.5% solution

Intervention Type: 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

Interventions

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension

Intervention Type: DRUG

Brinzolamide/brimonidine vehicle

Inactive ingredients used as placebo comparator

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

SIMBRINZA® suspension; DUOTRAV®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Assoc Global Trial Director, TM Ophtha

Role: STUDY_DIRECTOR

Alcon Research

Locations

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

Fort Worth, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-000176-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLJ576-P001

Identifier Type: -

Identifier Source: org_study_id