Phase 4
N=1
Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT03150160 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Mean Change From Baseline in Diurnal IOP at Week 6
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- brinzolamide 1%/brimonidine 0.2% fixed combination (Drug); Placebo (Drug); travoprost 0.004% ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Diurnal IOP at Week 6 |
— | — |
| SECONDARY Percent Change From Baseline in IOP at Week 6 |
— | — |
| SECONDARY Mean Diurnal IOP at Week 6 |
— | — |
| SECONDARY Mean Change From Baseline in IOP for Each Time Point at Week 6 |
— | — |
| SECONDARY Percentage Change From Baseline in IOP for Each Time Point at Week 6 |
— | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03150160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.