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Efficacy Study of Travoprost APS Versus TRAVATAN

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00848536
First received: February 19, 2009
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
 Drug: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution
Drug: Travoprost 0.004% (BAK-preserved) Eye Drops, Solution
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure at 9:00 am [ Time Frame: 3 months (measured at 9:00 am) ] [ Designated as safety issue: No ]

    For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg

    All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.

    Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis


  • Mean Intraocular Pressure at 11:00 am [ Time Frame: 3 months (measured at 11:00 am) ] [ Designated as safety issue: No ]

    For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg

    All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.

    Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis


  • Mean Intraocular Pressure at 4:00 pm [ Time Frame: 3 months (measured at 4:00 pm) ] [ Designated as safety issue: No ]

    For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg

    All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.

    Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis



Enrollment: 371
Study Start Date: March 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRAVATAN APS
One drop once daily in the evening for 3 months
 Drug: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution
One drop once daily in the evening for 3 months
Active Comparator: TRAVATAN
One drop once daily in the evening for 3 months
 Drug: Travoprost 0.004% (BAK-preserved) Eye Drops, Solution
One drop once daily in the evening for 3 months

  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, either gender and any race.
  • Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
  • Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy.

  • All patients: Mean IOP in same eye (at both Eligibility 1 & 2 Visits):

    ≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM & 4 PM.

  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Females of childbearing potential not meeting conditions set in the protocol.
  • Severe central visual field loss.
  • Angle Shaffer grade < 2.
  • Cup/disc ratio > 0.8 (horizontal or vertical measurement).
  • Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal).
  • Intraocular surgery or trauma within last 6 months.
  • Any abnormality preventing reliable applanation tonometry.
  • History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study.
  • Allergy/hypersensitivity to study medications.
  • Unable to discontinue use of all IOP-lowering medications for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit.
  • Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP.
  • Use of any additional topical or systemic ocular hypotensive medication during the study.
  • Therapy with another investigational agent within 30 days prior to the Screening visit.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00848536     History of Changes
Other Study ID Numbers: C-08-40, 2008-006027-31
Study First Received: February 19, 2009
Results First Received: February 14, 2011
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
OAG
OHT

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Tetrahydrozoline
Travoprost
Nasal Decongestants
 Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 23, 2013