Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension.
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | October 2013 |
| End Date: | November 2014 |
| Contact: | Alcon Call Center |
| Email: | alcon.medinfo@alcon.com |
| Phone: | 1-888-451-3937 |
Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1% /Brimonidine 0.2% Fixed Dose Combination Therapy
The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period
using Simbrinza™ topical ophthalmic suspension.
using Simbrinza™ topical ophthalmic suspension.
This study will consist of two phases. Phase I is the Screening/Eligibility Phase, which
includes a Screening Visit during which the subject will washout of all other IOP-lowering
medications, followed by one Eligibility Visit. Only subjects meeting all requirements of
inclusion and exclusion criteria will be treated in the next phase. Phase II is the
treatment phase, which includes visits at Week 2/Day 14 and Week 4/Day 30 (Exit Visit).
Both phases will require the subject to complete an overnight stay.
includes a Screening Visit during which the subject will washout of all other IOP-lowering
medications, followed by one Eligibility Visit. Only subjects meeting all requirements of
inclusion and exclusion criteria will be treated in the next phase. Phase II is the
treatment phase, which includes visits at Week 2/Day 14 and Week 4/Day 30 (Exit Visit).
Both phases will require the subject to complete an overnight stay.
Inclusion Criteria:
- Have a clinical diagnosis of either open-angle glaucoma or ocular hypertension in
both eyes.
- Have a mean IOP measurement in at least 1 eye greater than or equal to 21 and less
than 36 millimeters mercury (mmHg) at 8 AM during the Eligibility visit.
- Ability to wash out previous IOP lowering medication and meet IOP entry criteria.
- 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.
- Cannot safely undergo the initial wash-out period discontinuing all IOP-lowering
ocular medication(s) for a minimum of 5 (±1 day) to 28 (±1 day) days prior to
Eligibility Visit 1.
- Chronic, recurrent or severe inflammatory eye disease (e.g. scleritis, uveitis,
herpes keratitis).
- 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 such as retinal degeneration,
diabetic retinopathy, or retinal detachment.
- Best Corrected Visual Acuity (BCVA) score worse than approximately 20/80 Snellen.
- Other ocular pathology, including severe dry eye, that may in the opinion of the
investigator preclude the administration of study medication.
- Any abnormality preventing reliable measurement of IOP.
- Any other conditions including severe illness which would make the patient, in the
opinion of the Investigator, unsuitable for the study.
- Therapy with another investigational agent within 30 days prior to the Screening
Visit.
- Any medical condition that would preclude the safe administration of a topical
beta-blocker.
- Patients who cannot safely discontinue all glucocorticoids administered by any route.
- Other protocol-specified exclusion criteria may apply.
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