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An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Travoprost 0.004% ophthalmic solution
Bimatoprost 0.01% ophthalmic solution
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Ocular hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
  • Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
  • IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
  • Able to follow instructions and be willing and able to attend all study visits.
  • Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
  • Must read, sign, and date an Ethics Committee-approved informed consent form.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
  • Any abnormality preventing reliable applanation tonometry in either eye.
  • Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
  • Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
  • History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications).
  • Contact lens wear.
  • Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
  • Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
  • Women of childbearing potential not using reliable means of birth control, are pregnant, or lactating.
  • Unwilling to risk the possibility of darkened iris or eyelash changes.
  • Participation in any other investigational study within 30 days prior to the Screening Visit.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    TRAVATAN

    LUMIGAN

    Arm Description

    Travoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months

    Bimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months

    Outcomes

    Primary Outcome Measures

    Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.

    Secondary Outcome Measures

    Mean Change From Baseline in IOP at Week 6 and Month 3
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
    Percentage of Subjects Who Reached Target IOP at Each Visit
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
    Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit
    Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
    Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6
    Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
    Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6
    Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
    Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6
    The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is "None of the time" and 4 is "All of the time." A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health.
    Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6
    TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.

    Full Information

    First Posted
    August 10, 2012
    Last Updated
    July 13, 2015
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01664039
    Brief Title
    An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®
    Official Title
    Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (Travoprost 0.004%) Versus LUMIGAN® 0.01% Solution With BAK (Bimatoprost 0.01%) in Treatment Naïve Patients With Ocular Hypertension or Open Angle Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Ocular Hypertension
    Keywords
    Glaucoma, Ocular hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    104 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TRAVATAN
    Arm Type
    Experimental
    Arm Description
    Travoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months
    Arm Title
    LUMIGAN
    Arm Type
    Active Comparator
    Arm Description
    Bimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost 0.004% ophthalmic solution
    Other Intervention Name(s)
    TRAVATAN®
    Intervention Description
    Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative
    Intervention Type
    Drug
    Intervention Name(s)
    Bimatoprost 0.01% ophthalmic solution
    Other Intervention Name(s)
    LUMIGAN®
    Intervention Description
    Ophthalmic solution containing benzalkonium chloride (BAK)
    Primary Outcome Measure Information:
    Title
    Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6
    Description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
    Time Frame
    Baseline (Day 0), Month 6
    Secondary Outcome Measure Information:
    Title
    Mean Change From Baseline in IOP at Week 6 and Month 3
    Description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
    Time Frame
    Baseline (Day 0), Week 6, Month 3
    Title
    Percentage of Subjects Who Reached Target IOP at Each Visit
    Description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
    Time Frame
    Week 6, Month 3, Month 6
    Title
    Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit
    Description
    Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
    Time Frame
    Baseline (Day 0), Week 6, Month 3, Month 6
    Title
    Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6
    Description
    Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
    Time Frame
    Baseline (Day 0), Month 3, Month 6
    Title
    Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6
    Description
    Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
    Time Frame
    Baseline (Day 0), Month 3, Month 6
    Title
    Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6
    Description
    The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is "None of the time" and 4 is "All of the time." A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health.
    Time Frame
    Baseline (Day 0), Month 3, Month 6
    Title
    Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6
    Description
    TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
    Time Frame
    Baseline (Day 0), Month 3, Month 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment. Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye. IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. Able to follow instructions and be willing and able to attend all study visits. Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye. Must read, sign, and date an Ethics Committee-approved informed consent form. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator. Any abnormality preventing reliable applanation tonometry in either eye. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids. History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications). Contact lens wear. Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit. Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study. Women of childbearing potential not using reliable means of birth control, are pregnant, or lactating. Unwilling to risk the possibility of darkened iris or eyelash changes. Participation in any other investigational study within 30 days prior to the Screening Visit. Other protocol-defined exclusion criteria may apply.

    12. IPD Sharing Statement

    Learn more about this trial

    An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®

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