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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: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

The objective of this study is to assess the efficacy and tolerability of TRAVATAN® Solution without benzalkonium chloride (BAK) after changing from prior latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy in patients with open-angle glaucoma or ocular hypertension due to tolerability issues.


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
 Drug: Travoprost 0.004% without BAK containing Polyquad (PQ) preservative
 Phase 4

Study Type: Interventional
Study Design: 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 (Travoprost 0.004%) in Patients Previously on Latanoprost 0.005% or Bimatoprost 0.01% Ophthalmic Solution Monotherapy

Resource links provided by NLM:

Drug Information available for: Travoprost
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change in Intra-Ocular Pressure (IOP) at 12 weeks from Prior Therapy (baseline) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Goldmann applanation tonometry will be performed at the baseline visit and at the 12-week visit to record intra-ocular pressure. The difference between the two readings will be recorded as the change in IOP. Intra-ocular pressure will be measured in mmHg.


Secondary Outcome Measures:
  • Percentage of patients who reach target IOP (≤18 mmHg) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Goldmann applanation tonometry will be performed at the 12-week visit to record intra-ocular pressure. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤ 18 mmHg to the overall study population.


Enrollment: 201
Study Start Date: November 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
One drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
 Drug: Travoprost 0.004% without BAK containing Polyquad (PQ) preservative
Commercially marketed ophthalmic solution without BAK (benzalkonium chloride), containing Polyquad® Preservative, to be used as indicated per recommended dosage and administration.
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:

  • 18 years of age or older.
  • 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.
  • Intra-ocular pressure (IOP) less than 30 mmHg in both eyes while on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy.
  • 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.
  • Women who are pregnant or lactating.
  • Participation in any other investigational study within 30 days of Screening Visit.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493427

Locations
Spain
Call Alcon Call Center for Trial Locations
Madrid, Spain, 28034
Sponsors and Collaborators
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, 2011-003816-21
Study First Received: December 14, 2011
Last Updated: February 21, 2013
Health Authority: Belgium: Ethics Committee
Spain: Ethics Committee
Sweden: Institutional Review Board
Germany: Ethics Commission
United States: Food and Drug Administration

Keywords provided by Alcon Research:
Glaucoma

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

ClinicalTrials.gov processed this record on May 16, 2013