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Efficacy Study of Travoprost APS Versus TRAVATAN

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ClinicalTrials.gov Identifier: NCT00848536
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : March 8, 2011
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 371 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2009
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
Drug Information available for: Travoprost
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Mean Intraocular Pressure at 9:00 am [ Time Frame: 3 months (measured at 9:00 am) ]

    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


  2. Mean Intraocular Pressure at 11:00 am [ Time Frame: 3 months (measured at 11:00 am) ]

    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


  3. Mean Intraocular Pressure at 4:00 pm [ Time Frame: 3 months (measured at 4:00 pm) ]

    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




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00848536     History of Changes
Other Study ID Numbers: C-08-40
2008-006027-31 ( EudraCT Number )
First Posted: February 20, 2009    Key Record Dates
Results First Posted: March 8, 2011
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by Alcon Research:
OAG
OHT

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