NCT01978600

Brief Summary

The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 13, 2015

Completed
Last Updated

April 13, 2015

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

October 30, 2013

Results QC Date

March 31, 2015

Last Update Submit

March 31, 2015

Conditions

Open-Angle GlaucomaOcular Hypertension

Keywords

Open-Angle GlaucomaOcular HypertensionSimbrinza™Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • Mean Nocturnal IOP at Week 4

    Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

    Week 4: 10PM, 12AM, 2AM, 4AM, 6AM

Secondary Outcomes (2)

  • Mean Diurnal IOP at Week 4

    Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM

  • Mean 24-hour IOP at Week 4

    Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM

Study Arms (2)

SIMBRINZA™

EXPERIMENTAL

Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks

Drug: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension

Timolol Maleate 0.5%

ACTIVE COMPARATOR

Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks

Drug: Timolol Maleate 0.5%

Interventions

Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspensionDRUG

Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Also known as: SIMBRINZA™
SIMBRINZA™
Timolol Maleate 0.5%DRUG

Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Also known as: TIMOPTIC™, TIMOPTIC-XE™, BETIMOL™, ISTALOL™
Timolol Maleate 0.5%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
  • Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
  • Must sign an Informed Consent form.

You may not qualify if:

  • Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
  • Severe central visual field loss in either eye.
  • Chronic, recurrent or severe inflammatory eye disease.
  • Ocular trauma or ocular surgery within the past 6 months.
  • Ocular infection or ocular inflammation within the past 3 months.
  • Clinically significant or progressive retinal disease.
  • Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication.
  • Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
  • Any medical condition that would preclude the safe administration of a topical beta-blocker.
  • Cannot safely discontinue all glucocorticoids administered by any route.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

brinzolamideBrimonidine TartrateTimolol

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingMorpholinesOxazines

Results Point of Contact

Title
Doug Hubatsch, Global Brand Leader, Medical Affairs, Glaucoma
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Danyel Carr, MS

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 7, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 13, 2015

Results First Posted

April 13, 2015

Record last verified: 2015-03