GLJ576-P001 Saftey and Efficacy of SIMBRINZA BID V1.0
Research type
Research Study
Full 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)
IRAS ID
206982
Contact name
Sheng Lim
Contact email
Sponsor organisation
Alcon Research Ltd.
Eudract number
2016-000176-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 26 days
Research summary
This is a multi-national, multi-centre, interventional, randomized, double masked, placebo-controlled Phase IV clinical study with the IMP Simbrinza. It will enroll adult subjects with open-angle glaucoma or ocular hypertension on DuoTrav who may benefit from further IOP lowering.
Simbrinza is a fixed dose combination eye drop containing a carbonic anhydrase inhibitor, brinzolamide 10 mg/mL, and an alpha agonist, brimonidine 2 mg/mL which lower lOP by complementary mechanisms of action. Simbrinza received EU Marketing Authorisation in July 2014. The background medication, DuoTrav, is a well-established, commonly used, topical IOP lowering fixed dose combination eye drop containing a topical PGA, travoprost 40 μg/mL, and a topical beta-adrenergic receptor blocking agent, timolol 5 mg/mL, which also lower lOP by complementary mechanisms of action.
The objective of the study is to evaluate the additive IOP lowering effect of Simbrinza used concomitantly with DuoTrav. Approximately 240 subjects are to be randomised and subjects should have been on continuous evening therapy with DuoTrav for at least 28 days prior to randomisation. Following randomization in a 1:1 ratio subjects will receive additional treatment with Simbrinza or placebo for 6 weeks.REC name
HSC REC A
REC reference
16/NI/0098
Date of REC Opinion
15 Jun 2016
REC opinion
Further Information Favourable Opinion