Simbrinza BID Adjunctive to PGA
Research type
Research Study
Full title
Additive Effect of Twice Daily Brinzolamide 1% /Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue
IRAS ID
182226
Contact name
Kin Sheng Lim
Contact email
Sponsor organisation
Alcon Research Limited
Eudract number
2015-000736-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Sponsor's project number, A02077
Duration of Study in the UK
1 years, 3 months, days
Research summary
Glaucoma is a group of progressive optic neuropathies that may results in damage to the optic nerve and loss of vision if left untreated. Among the various treatment options currently available, prostaglandin analogues (PGAs) are often preferred as initial monotherapy because of their efficacy in lowering the pressure in the eye, low frequency of systemic side effects, and lower frequency of instillation compared with older therapies. Despite the efficacy of the PGAs, a significant proportion of subjects require more than one medication to reach a target IOPs.
The purpose of this research study is to demonstrate the eye-pressure lowering ability of a fixed combination of SIMBRINZA™ (Brinzolamide 1% /Brimonidine 0.2%) in research participants who are also on a prostaglandin analogue such as TRAVATAN® 0.004% (Travoprost), or LUMIGAN® 0.01% (Bimatoprost), or XALATAN® 0.005% (Latanoprost) compared to the effect and eye-pressure lowering ability of using a prostaglandin analogue alone.
This is a multicenter, randomized, double-masked, parallel-group study. Approximately 280 adult men and women will be enrolled in approximately 35 sites in Europe, Australia, Latin America and Canada.
2 research sites in UK will participate in this research and will randomize approximately 8 patients each. The enrollment is competitive, the number of patients may vary from site to site, with no more than 27 subjects at one site.
The participants will be randomized into 1 of 6 groups:
• SIMBRINZA (eye drops dosed 2 times daily) + TRAVATAN (eye drops dosed daily),
• SIMBRINZA (eye drops dosed 2 times daily) + LUMIGAN (eye drops dosed daily),
• SIMBRINZA (eye drops dosed 2 times daily) + XALATAN (eye drops dosed daily),
or
• Placebo (eye drops dosed 2 times daily) + TRAVATAN (eye drops dosed daily),
• Placebo (eye drops dosed 2 times daily) + LUMIGAN (eye drops dosed daily),
• Placebo (eye drops dosed 2 times daily) + XALATAN (eye drops dosed daily)
The expected duration of subjects participation is approximately 11 weeks.REC name
London - Central Research Ethics Committee
REC reference
15/LO/1232
Date of REC Opinion
1 Sep 2015
REC opinion
Further Information Favourable Opinion