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Novartis CSR template

Clinical DevelopmentQVJ499 CQVJ499A2404 / NCT03150160A 6- week, Double Masked, Placebo-Controlled study to Evaluate the Efficacy and Safety of Twice-daily Brinzolamide 1% / Brimonidine Fixed Dose Combination as an Adjunctive Therapy to Travoprost in Reducing Intraocular Pressure in Patients With Normal Tension GlaucomaDocument type:Abbreviated Clinical study Report Development phase:IV Property of NovartisConfidentialMay not be used, divulged, published or otherwise disclosedwithout the consent of NovartisTemplate version Jan 20, 20141 study informationStudy title: A 6-week, Double Masked, Placebo-Controlled study to Evaluate the Efficacy and Safety of Twice-daily Brinzolamide 1% / Brimonidine Fixed Dose Combination as an Adjunctive Therapy to Travoprost in Reducing Intraocular Pressure in Patients With Normal Tension Glaucoma Test drug/investigational product: Brinzolamide 1%/Brimonidine / QVJ499 Indication studied: Normal tension glaucoma study design : See study titleSponsor: NovartisProtocol identification: Protocol no.

9.1 Study design Figure 9-1 Study design BID: twice a day, QD: once a day. This was a multicenter, randomized, double-masked, two-arm, placebo-controlled, parallel-group study in patients with normal tension glaucoma who were insufficiently controlled on travoprost 0.004% (Travatan) monotherapy. Approximately 200 patients were planned to be

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