6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Condition(s) targeted: Glaucoma; Ocular Hypertension

Intervention: Dose Level A / Brinzolamide 1% ophthalmic suspension (Drug); Dose Level B / Brinzolamide 1% ophthalmic suspension (Drug); Dose Level C / Brinzolamide 1% ophthalmic suspension (Drug); Brinzolamide 1% ophthalmic suspension AZOPT® (Drug); Travoprost 0.004% ophthalmic solution TRAVATAN Z® (Drug); Travoprost solution vehicle (Drug); Brinzolamide suspension vehicle (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
James E. Teague, BS, Study Director, Affiliation: Alcon Research

The purpose of this study is to evaluate Travoprost/Brinzolamide fixed combination (Trav/Brinz) administered twice daily as compared to each of its marketed components (TRAVATAN Z® solution and AZOPT® suspension) and to the unfixed combination of TRAVATAN Z® plus AZOPT® in lowering intraocular pressure (IOP).

Official title: A 6-Week Proof-of-Concept Study Evaluating the Safety and IOP-Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean IOP at Week 6

Detailed description: This study is divided into two phases conducted in sequence. Phase I is the Screening/Eligibility Phase, which includes a Screening Visit, followed by two Eligibility Visits. Phase II is the randomized, double-masked, 6-week Treatment Phase which includes on-therapy visits at Week 2 and Week 6.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosed with open-angle glaucoma (including open-angle glaucoma with

pseudoexfoliation or pigment dispersion) or ocular hypertension;

- IOP within the protocol-specified range at both the Eligibility 1 and 2 Visits. Mean

IOP 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:

- Woman of childbearing potential who is currently pregnant, intends to become pregnant

during the study period, breastfeeding, or not using adequate birth control methods to prevent pregnancy throughout the study;

- Unable to discontinue all IOP-lowering ocular medication(s) per the appropriate

washout schedule prior to the E1 Visit;

- Chronic, recurrent or severe inflammatory eye disease;

- Ocular trauma within the past 6 months prior to the Screening Visit;

- Ocular infection or ocular inflammation within the past 3 months prior to the

Screening Visit;

- Clinically relevant 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, in the opinion of the

Investigator, preclude the administration of a topical prostaglandin analogue or topical carbonic anhydrase inhibitor;

- Intraocular surgery within the past 6 months prior to the Screening Visit;

- Ocular laser surgery within the past 3 months prior to the Screening Visit;

- Any abnormality preventing reliable applanation tonometry;

- Any other conditions including severe illness which would make the subject, in the

opinion of the Investigator, unsuitable for the study;

- History of hepatic or renal disease that would preclude the safe administration of a

carbonic anhydrase inhibitor (CAI) in the opinion of the Investigator;

- Hypersensitivity to prostaglandin analogues, topical or oral CAIs, sulfonamide

derivatives, or to any component of the study medications in the opinion of the Investigator;

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

salicylate therapy;

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

study;

- Concurrent use of glucocorticoids administered by any route;

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

(excluding the IOP-lowering treatments) or substances administered by any route and used on a chronic basis that may affect IOP (ie, β adrenergic blocking agents);

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

Visit;

- Other protocol-specified exclusion criteria may apply.

Contact Alcon Call Center for Trial Locations, Fort Worth, Texas 76134, United States

Starting date: June 2014
Last updated: November 20, 2014