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Efficacy of Changing to TRAVATAN® From Prior Therapy

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Travoprost 0.004% BAK-free
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Glaucoma, Open-angle glaucoma, Ocular hypertension, Hypertension, Eye Diseases, Vascular Diseases, Cardiovascular Diseases, Travoprost, Antihypertensive Agents, Cardiovascular Agents, Therapeutic Uses, Pharmacologic Actions

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye;
  • On latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the investigator;
  • Intraocular pressure (IOP) <30 millimeters of mercury (mmHg) in both eyes while on latanoprost ophthalmic solution 0.005% monotherapy;
  • IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period;
  • Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study;
  • Able to follow instructions and 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 sign an informed consent form;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator;
  • Any abnormality preventing reliable applanation tonometry in either eye;
  • Corneal dystrophies in either eye;
  • Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye;
  • Any clinically significant, serious, or severe medical condition;
  • Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study;
  • Severe dry eye or keratoconjunctivitis sicca which has been or is currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids;
  • Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit;
  • Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment;
  • Progressive retinal or optic nerve disease from any cause;
  • Women who are pregnant, lactating, or not using reliable means of birth control;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    TRAVATAN® BAK-free

    Arm Description

    Travoprost 0.004% BAK-free, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). 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 efficacy analysis.

    Secondary Outcome Measures

    Percentage of Subjects Who Reach Target IOP (≤18 mmHg)
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

    Full Information

    First Posted
    January 11, 2012
    Last Updated
    May 15, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01510145
    Brief Title
    Efficacy of Changing to TRAVATAN® From Prior Therapy
    Official Title
    Multi-Center Study Comparing Efficacy and Tolerability of TRAVATAN® BAK-free (0.004% Travoprost) in Patients Previously on Latanoprost Ophthalmic Solution 0.005% Monotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    May 2013 (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 was to assess the efficacy and tolerability of TRAVATAN® solution without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to tolerability issues.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open-angle Glaucoma, Ocular Hypertension
    Keywords
    Glaucoma, Open-angle glaucoma, Ocular hypertension, Hypertension, Eye Diseases, Vascular Diseases, Cardiovascular Diseases, Travoprost, Antihypertensive Agents, Cardiovascular Agents, Therapeutic Uses, Pharmacologic Actions

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    191 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TRAVATAN® BAK-free
    Arm Type
    Experimental
    Arm Description
    Travoprost 0.004% BAK-free, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost 0.004% BAK-free
    Other Intervention Name(s)
    TRAVATAN® BAK-free
    Intervention Description
    Containing Polyquad (PQ) preservative
    Primary Outcome Measure Information:
    Title
    Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)
    Description
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). 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 efficacy analysis.
    Time Frame
    Baseline, Week 12
    Secondary Outcome Measure Information:
    Title
    Percentage of Subjects Who Reach Target IOP (≤18 mmHg)
    Description
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
    Time Frame
    Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye; On latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the investigator; Intraocular pressure (IOP) <30 millimeters of mercury (mmHg) in both eyes while on latanoprost ophthalmic solution 0.005% monotherapy; IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period; Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study; Able to follow instructions and 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 sign an informed consent form; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator; Any abnormality preventing reliable applanation tonometry in either eye; Corneal dystrophies in either eye; Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye; Any clinically significant, serious, or severe medical condition; Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study; Severe dry eye or keratoconjunctivitis sicca which has been or is currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids; Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit; Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment; Progressive retinal or optic nerve disease from any cause; Women who are pregnant, lactating, or not using reliable means of birth control; Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adriana S. Bonadia
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26563363
    Citation
    Lopes JF, Hubatsch DA, Amaris P. Effect of benzalkonium chloride-free travoprost on intraocular pressure and ocular surface symptoms in patients with glaucoma previously on latanoprost: an open-label study. BMC Ophthalmol. 2015 Nov 12;15:166. doi: 10.1186/s12886-015-0151-7.
    Results Reference
    derived

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    Efficacy of Changing to TRAVATAN® From Prior Therapy

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