Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Official title:

Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978600
• Other study ID #: M-13-037
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2013
• Last updated: March 31, 2015
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• 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.

• Other protocol-specified exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension
Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
• Timolol Maleate 0.5%
Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean Diurnal IOP at Week 4	Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). 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: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM	No
Secondary	Mean 24-hour IOP at Week 4	24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM 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: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM	No