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Efficacy of Changing to Travatan From Prior Therapy

This study is currently recruiting participants.
Verified April 2013 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01510145
First received: January 11, 2012
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to assess the efficacy and tolerability of TRAVATAN® solution without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% 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 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:

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 ]
    Goldman 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 IOP. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤18mmHg to the overall study population.


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 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 a 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.
  • Intra-ocular pressure (IOP) ≤30 mmHg in both eyes while on latanoprost ophthalmic solution 0.005% monotherapy.
  • 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.
  • Corneal dystrophies.
  • 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.
  • 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.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510145

Contacts
Contact: Alcon Call Center 1-888-451-3937

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
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
Last Updated: April 22, 2013
Health Authority: Argentina: Human Research Bioethics Committee

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