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Efficacy Study of Travoprost APS Versus TRAVATAN
This study is not yet open for participant recruitment.
Verified by Alcon Research, February 2009
First Received: February 19, 2009   No Changes Posted
Sponsored by: Alcon Research
Information provided by: Alcon Research
ClinicalTrials.gov Identifier: NCT00848536
  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 Hypetersion


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
Drug: Travoprost APS
Drug: TRAVATAN
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Efficacy: Mean IOP [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: March 2009
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Travoprost APS
Drug: Travoprost APS
Eye Drops, Solution, once daily
2: Active Comparator
TRAVATAN
Drug: TRAVATAN
Eye Drops, Solution, once daily

  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
  • OAG or 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
    • 21 and ≤ 36 mmHg at 11 AM & 4 PM

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 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 IOP-lowering medication 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848536

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

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research Ltd ( Miguel Martinez, M.D., Ph.D./Global Study Manager )
Study ID Numbers: C-08-40, Eudract number: 2008-006027-31
Study First Received: February 19, 2009
Last Updated: February 19, 2009
ClinicalTrials.gov Identifier: NCT00848536     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
OAG
OHT

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Agents
Tetrahydrozoline
Antihypertensive Agents
Travoprost
Hypertension
Ocular Hypertension

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

ClinicalTrials.gov processed this record on August 30, 2009