Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma

Novartis

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Drug: brinzolamide 1%/brimonidine 0.2% fixed combination; Drug: travoprost 0.004% ophthalmic solution; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03150160

CQVJ499A2404

Details and patient eligibility

About

The purpose of this study was to determine the incremental intraocular pressure (IOP) lowering that is achieved when Simbrinza is used adjunctively to Travatan in patients with normal tension glaucoma that may benefit from further IOP lowering.

Full description

This study was prematurely terminated due to administrative reasons and not due to any safety or efficacy concerns.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign written informed consent
• Diagnosed with normal tension glaucoma
• Intraocular pressure measurements in at least 1 eye as specified in the protocol
• Willing and able to attend all study visits

Exclusion criteria

• History of hypersensitivity to any of the study drugs
• Use of medications prohibited by the protocol
• Pregnant or nursing
• Of child-bearing potential unless using contraception, as specified in the protocol
• Any form of glaucoma other than open angle glaucoma in either eye
• Chronic, recurrent or severe inflammatory eye disease
• Ocular trauma or surgery within the past 6 months in either eye; ocular infection or laser surgery within the past 3 months in either eye (all from screening)
• Conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups, including a placebo group

Simbrinza + Travatan

Experimental group

Description:

Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution

Treatment:

Drug: travoprost 0.004% ophthalmic solution

Drug: brinzolamide 1%/brimonidine 0.2% fixed combination

Placebo + Travatan

Placebo Comparator group

Description:

Placebo + travoprost 0.004% ophthalmic solution

Treatment:

Drug: Placebo

Drug: travoprost 0.004% ophthalmic solution