Efficacy of Changing to TRAVATAN® From Prior Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01493427
First received: December 14, 2011
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® Solution without benzalkonium chloride (BAK) in patients previously on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy.


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
Drug: Travoprost 0.004%
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Center Study Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (0.004% Travoprost) in Patients Previously on Latanoprost 0.005% or Bimatoprost 0.01% Ophthalmic Solution Monotherapy

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean 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 Patients With Target IOP (≤18 mmHg) at 12 Weeks [ 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: 202
Study Start Date: December 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRAVATAN® BAK-free
Travoprost 0.004%, 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%
Travoprost 0.004% without benzalkonium chloride (BAK), 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.
  • Be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK-containing generics) for at least four weeks prior to Screening visit.
  • Would benefit from a switch to TRAVATAN® Solution without BAK containing Polyquad® Preservative due to tolerability issues, in the opinion of the investigator.
  • 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.
  • Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye
  • 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.
  • Severe dry eye or related which has been or currently is being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
  • Any clinically significant, serious, or severe medical condition.
  • Intraocular conventional surgery or laser surgery in either eye less than three months prior to 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.
  • Women not using reliable means of birth control.
  • Use of any systemic medication known to affect IOP which has not been on stable course for at least 7 days prior to Screening Visit.
  • Any clinically significant, serious, or severe medical condition.
  • Participation in any other investigational study within 30 days of Screening Visit.
  • 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: NCT01493427

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Severine Durier, Pharm.D Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01493427     History of Changes
Other Study ID Numbers: RDG-10-298, 2011-000161-13
Study First Received: December 14, 2011
Results First Received: February 17, 2014
Last Updated: May 9, 2014
Health Authority: Belgium: Ethics Committee
Spain: Ethics Committee
Sweden: Institutional Review Board
Italy: Ethics Committee

Keywords provided by Alcon Research:
Glaucoma
OAG
OHT

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

ClinicalTrials.gov processed this record on October 23, 2014