Efficacy of Changing to TRAVATAN® From Prior Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01510145
First received: January 11, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
Drug: Travoprost 0.004% BAK-free
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 191
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRAVATAN® BAK-free
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.
Drug: Travoprost 0.004% BAK-free
Containing Polyquad (PQ) preservative
Other Name: TRAVATAN® BAK-free

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510145

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Adriana S. Bonadia Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01510145     History of Changes
Other Study ID Numbers: RDG-10-300
Study First Received: January 11, 2012
Results First Received: May 15, 2014
Last Updated: May 15, 2014
Health Authority: Argentina: Human Research Bioethics Committee
Chile: Institutional Review Board
Colombia: Institutional Review Board

Keywords provided by Alcon Research:
Glaucoma
Open-angle glaucoma
Ocular hypertension
Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014