Clinical trial NCT02730871: Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®
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®)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-04-07
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Mean Diurnal IOP at Week 6
timeFrame: Week 6
measure: Mean Percentage Change From Baseline in Diurnal IOP at Week 6
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in IOP (09:00, 11:00) at Week 6
timeFrame: Baseline, Week 6
measure: Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon for Locations (Europe, Asia, and Latin America)
state: Texas
Study officials:
affiliation: Alcon Research
name: Assoc Global Trial Director, TM Ophtha
role: STUDY_DIRECTOR
References: