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OpenTrials
Completed

NCT Number: NCT03150160

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Low Tension Glaucoma Ocular Hypertension Optic Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Seoul, 03080, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

brinzolamide 1%/brimonidine 0.2% fixed combination

Drug

One drop applied topically to the affected eye(s) in the morning and evening

Other names: Simbrinza

Placebo

Drug

One drop applied topically to the affected eye(s) in the morning and evening

Travoprost 0.004% ophthalmic solution

Drug

One drop applied topically to the affected eye(s) in the evening

Other names: Travatan

Primary outcomes

  1. Mean Change From Baseline in Diurnal IOP at Week 6

    Time frame: Baseline, Week 6

    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry in millimeters mercury (mmHg). Diurnal IOP was defined as the average of the 9:00 am and 11:00 am time points. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.

Secondary outcomes

  1. Percent Change From Baseline in IOP at Week 6

    Time frame: Baseline, Week 6

    IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.

  2. Mean Diurnal IOP at Week 6

    Time frame: Week 6

    IOP was measured by Goldmann applanation tonometry in mmHg. Diurnal IOP was defined as the average of the 9:00 and 11:00 time points. One (study eye) contributed to the analysis.

  3. Mean Change From Baseline in IOP for Each Time Point at Week 6

    Time frame: Baseline (9:00 am and 11:00 am), Week 6 (9:00 am and 11:00 am)

    IOP was measured by Goldmann applanation tonometry in mmHg. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.

  4. Percentage Change From Baseline in IOP for Each Time Point at Week 6

    Time frame: Baseline, Week 6

    IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 6-week, Double Masked, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Twice-daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to Travoprost 0.004% in Reducing Intraocular Pressure in Patients With Normal Tension Glaucoma

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 12, 2017
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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