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Completed

NCT Number: NCT02419508

SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)

The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

About this study

This study consisted of 2 sequential phases: Screening/Eligibility Phase, followed by a Masked Treatment Phase (Phase II). Subjects were assigned into one of 3 PGA therapy groups for the duration of the study, based upon commercial availability.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of either open-angle glaucoma or ocular hypertension;
  • Must sign an informed consent form;
  • Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:00.
  • Willing and able to attend all study visits;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;
  • Any form of glaucoma other than open-angle glaucoma or ocular hypertension;
  • Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;
  • Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension

Drug

Other names: SIMBRINZA® suspension

Brinz/brim vehicle

Drug

Inactive ingredients used as a placebo for masking purposes

Prostaglandin analogue

Drug

Other names: TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%), LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%), XALATAN® (Latanoprost ophthalmic solution, 0.005%)

Primary outcomes

  1. Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6

    Time frame: Baseline, Week 6

    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

Secondary outcomes

  1. Mean Diurnal IOP at Week 6

    Time frame: Week 6

    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.

  2. Mean Percentage Change From Baseline in Diurnal IOP at Week 6

    Time frame: Baseline, Week 6

    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

  3. Mean Change From Baseline in IOP at 11:00 at Week 6

    Time frame: Baseline, Week 6

    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

  4. Mean Percentage Change From Baseline in IOP at 11:00 at Week 6

    Time frame: Baseline, Week 6

    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

  5. Mean Change From Baseline in IOP at 09:00 at Week 6

    Time frame: Baseline, Week 6

    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 09:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

  6. Mean Percentage Change From Baseline at 09:00 at Week 6

    Time frame: Baseline, Week 6

    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 9:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits.A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2015
Registry last updated
Nov 15, 2018

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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