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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 14, 2014
First Posted Date  ICMJE May 16, 2014
Results First Submitted Date  ICMJE November 24, 2015
Results First Posted Date  ICMJE December 29, 2015
Last Update Posted Date December 29, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
Mean IOP at Week 6 [ Time Frame: Week 6, up to 8 pm ]
IOP (fluid pressure inside the eye) will be 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).
Change History Complete list of historical versions of study NCT02140060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Official Title  ICMJE 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
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: Dose Level A / Brinzolamide 1% ophthalmic suspension
    Fixed combination
  • Drug: Dose Level B / Brinzolamide 1% ophthalmic suspension
    Fixed combination
  • Drug: Dose Level C / Brinzolamide 1% ophthalmic suspension
    Fixed combination
  • Drug: Brinzolamide 1% ophthalmic suspension AZOPT®
    Other Name: AZOPT®
  • Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®
    Other Name: TRAVATAN Z®
  • Drug: Travoprost solution vehicle
    Inactive ingredients used for masking purposes
  • Drug: Brinzolamide suspension vehicle
    Inactive ingredients used for masking purposes
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Dose Level A / Brinzolamide 1% ophthalmic suspension
    • Drug: Travoprost solution vehicle
  • 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
    Interventions:
    • Drug: Dose Level B / Brinzolamide 1% ophthalmic suspension
    • Drug: Travoprost solution vehicle
  • 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
    Interventions:
    • Drug: Dose Level C / Brinzolamide 1% ophthalmic suspension
    • Drug: Travoprost solution vehicle
  • 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
    Interventions:
    • Drug: Brinzolamide 1% ophthalmic suspension AZOPT®
    • Drug: Travoprost solution vehicle
  • 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
    Interventions:
    • Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®
    • Drug: Brinzolamide suspension vehicle
  • 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
    Interventions:
    • Drug: Brinzolamide 1% ophthalmic suspension AZOPT®
    • Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2014)
327
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2014)
288
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02140060
Other Study ID Numbers  ICMJE C-14-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sr. Clinical Manager, GCRA, Pharma Alcon Research
PRS Account Alcon Research
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP