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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140060
• Other study ID #: C-14-003
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2014
• Last updated: November 24, 2015
• Start date: June 2014
• Est. completion date: November 2014

Study information

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

Clinical Trial Summary

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).

Description:

This study was divided into two phases conducted in sequence. Phase I was the Screening/Eligibility Phase, which included a Screening Visit, followed by two Eligibility Visits. Phase II was the randomized, double-masked, 6-week Treatment Phase which included on-therapy visits at Week 2 and Week 6. Travoprost was administered in 1 of 3 concentration levels (A-C), where A=lowest and C=highest.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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, ß adrenergic blocking agents);

• Therapy with another investigational agent within 30 days prior to the Screening Visit;

• Other protocol-specified exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dose Level A / Brinzolamide 1% ophthalmic suspension
Fixed combination
• Dose Level B / Brinzolamide 1% ophthalmic suspension
Fixed combination
• Dose Level C / Brinzolamide 1% ophthalmic suspension
Fixed combination
• Brinzolamide 1% ophthalmic suspension AZOPT®

• Travoprost 0.004% ophthalmic solution TRAVATAN Z®

• Travoprost solution vehicle
Inactive ingredients used for masking purposes
• Brinzolamide suspension vehicle
Inactive ingredients used for masking purposes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean IOP at Week 6	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.	Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM	No