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

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ClinicalTrials.gov Identifier: NCT02140060
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : December 29, 2015
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief 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).

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: 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 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014


Arm Intervention/treatment
Experimental: TravA/Brinz
Dose Level A / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Drug: Dose Level A / Brinzolamide 1% ophthalmic suspension
Fixed combination

Drug: Travoprost solution vehicle
Inactive ingredients used for masking purposes

Experimental: TravB/Brinz
Dose Level B / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Drug: Dose Level B / Brinzolamide 1% ophthalmic suspension
Fixed combination

Drug: Travoprost solution vehicle
Inactive ingredients used for masking purposes

Experimental: TravC/Brinz
Dose Level C / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Drug: Dose Level C / Brinzolamide 1% ophthalmic suspension
Fixed combination

Drug: Travoprost solution vehicle
Inactive ingredients used for masking purposes

Active Comparator: AZOPT
Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
Drug: Brinzolamide 1% ophthalmic suspension AZOPT®
Other Name: AZOPT®

Drug: Travoprost solution vehicle
Inactive ingredients used for masking purposes

Active Comparator: TRAV Z
Brinzolamide suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®
Other Name: TRAVATAN Z®

Drug: Brinzolamide suspension vehicle
Inactive ingredients used for masking purposes

Active Comparator: TRAV Z + AZOPT
Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Drug: Brinzolamide 1% ophthalmic suspension AZOPT®
Other Name: AZOPT®

Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®
Other Name: TRAVATAN Z®




Primary Outcome Measures :
  1. Mean IOP at Week 6 [ Time Frame: Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140060


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Sr. Clinical Manager, GCRA, Pharma Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02140060     History of Changes
Other Study ID Numbers: C-14-003
First Posted: May 16, 2014    Key Record Dates
Results First Posted: December 29, 2015
Last Update Posted: December 29, 2015
Last Verified: November 2015
Keywords provided by Alcon Research:
Glaucoma
Ocular
Hypertension
OAG
POAG
OHT
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Travoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Brinzolamide
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action