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

February 19, 2009
April 4, 2012
March 2009
January 2010   (final data collection date for primary outcome measure)
  • 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

Efficacy: Mean IOP [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00848536 on ClinicalTrials.gov Archive Site
Not Provided
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Not Provided
 
Efficacy Study of Travoprost APS Versus TRAVATAN
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Open Angle Glaucoma
  • Ocular Hypertension
  • Drug: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution
    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
  • Experimental: TRAVATAN APS
    One drop once daily in the evening for 3 months
    Intervention: Drug: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution
  • Active Comparator: TRAVATAN
    One drop once daily in the evening for 3 months
    Intervention: Drug: Travoprost 0.004% (BAK-preserved) Eye Drops, Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
371
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00848536
C-08-40, 2008-006027-31
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP