Efficacy and Safety of Brinzolamide/Brimonidine Fixed Combination BID Compared to Brinzolamide BID Plus Brimonidine BID in Subjects With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Condition(s) targeted: Open-Angle Glaucoma; Ocular Hypertension

Intervention: Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension (Drug); Brinzolamide 10 mg/mL eye drops, suspension (Drug); Brimonidine 2 mg/mL eye drops, solution (Drug); Vehicle (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Miao Guo, Master, Clinical Medicine, Study Director, Affiliation: Alcon Research

Overall contact:
Alcon (China) Ophthalmic Product Co., LTD, Phone: 8610 58291588

The purpose of this study is to compare the fixed combination (BID) [Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL eyes drops, suspension] to the unfixed combination (BID) [Brinzolamide 10 mg/mL eye drops, suspension plus Brimonidine 2 mg/mL eyes drops, solution] with respect to intraocular pressure (IOP)-lowering efficacy. This study will take place in China, Taiwan, and Russia.

Official title: Efficacy and Safety of Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension Plus Brimonidine 2 mg/mL Eye Drops, Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean diurnal IOP change from baseline at Month 3

Detailed description: This study is divided into 2 phases conducted in sequence for a total of 6 visits: Phase I (Screening/Eligibility) which includes a Screening Visit, followed by 2 Eligibility Visits (E1 and E2) and Phase II (Treatment/Follow-up) which includes 3 visits at Week 2, Week 6, and Month 3. Following washout of any IOP-lowering medication, subjects who meet all inclusion/exclusion criteria at both Eligibility visits and had IOP measurements within the specified range during this period will be randomized to Phase II.

Minimum age: 18 Years. Maximum age: 95 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of open-angle glaucoma or ocular hypertension insufficiently controlled on

monotherapy or currently on multiple IOP-lowering medications;

- Mean IOP measurements within guidelines specified in the protocol. Must not be > 36

mmHg at any time point;

- Able to understand and sign an informed consent form;

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Women of childbearing potential who are pregnant, test positive for pregnancy, intend

to become pregnant during the study period, breast-feeding, or not in agreement to use adequate birth control methods throughout the study;

- Severe central visual field loss in either eye;

- Unable to safely discontinue all IOP-lowering ocular medication(s) for a minimum of 5

(± 1) to 28 (± 1) days prior to E1 Visit;

- Chronic, recurrent or severe inflammatory eye disease;

- Ocular trauma 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 55 ETDRS letters (equivalent to

approximately 0. 60 logMAR, 20/80 Snellen, or 0. 25 decimal);

- Other ocular pathology (including severe dry eye) that may preclude the

administration of α-adrenergic agonist and/or topical carbonic anhydrase inhibitor (CAI);

- Intraocular surgery within the past 6 months;

- Ocular laser surgery within the past 3 months;

- Any abnormality preventing reliable applanation tonometry;

- Any conditions including severe illness which would make the Subject, in the opinion

of the Investigator, unsuitable for the study;

- History of active, severe, unstable or uncontrolled cardiovascular, cerebrovascular,

hepatic, or renal disease that would preclude safe administration of a topical α-adrenergic agonist or CAI;

- Recent (within 4 weeks of the E1 Visit) use of high-dose (> 1 g daily) salicylate

therapy;

- Current or anticipated treatment with any psychotropic drugs that augment adrenergic

response (eg, desipramine, amitriptyline);

- Concurrent use of monoamine oxidase inhibitors (MAOI);

- Concurrent use of glucocorticoids administered by any route;

- Therapy with another investigational agent within 30 days prior to the Screening

Visit;

- Hypersensitivity to α-adrenergic agonist drugs, topical or oral CAIs, sulfonamide

derivatives, or to any component of the study medications;

- Less than 30 days stable dosing regimen before the Screening Visit of any medications

(excluding IOP-lowering treatments) or substances administered by any route and used on a chronic basis that may affect IOP, including but not limited to β-adrenergic blocking agents;

- Use of any additional topical or systemic ocular hypotensive medication during the

study;

- Other protocol-specified exclusion criteria may apply.

Alcon (China) Ophthalmic Product Co., LTD, Phone: 8610 58291588

Contact Alcon China for Trial Locations, Beijing 100016, China; Recruiting

Starting date: April 2015
Last updated: April 15, 2015