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Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%

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ClinicalTrials.gov Identifier: NCT01452009
Recruitment Status : Withdrawn (Management Decision)
First Posted : October 14, 2011
Last Update Posted : February 10, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: Travoprost Ophthalmic Solution, 0.004% (New Formulation) Drug: TRAVATAN® Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Three Month Safety and Efficacy Study of TRAVATAN® vs Travoprost Ophthalmic Solution, 0.004%
Study Start Date : November 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011


Arm Intervention/treatment
Experimental: Travoprost Ophthalmic Solution, 0.004% (New Formulation) Drug: Travoprost Ophthalmic Solution, 0.004% (New Formulation)
Travoprost Ophthalmic Solution, 0.004% given one drop once daily

Active Comparator: TRAVATAN®
TRAVATAN® administered one drop once daily
Drug: TRAVATAN®
TRAVATAN® administered one drop once daily




Primary Outcome Measures :
  1. Efficacy: mean IOP Efficacy as measured by mean IOP [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18 years of age or older
  2. Either gender
  3. Any race/ethnicity
  4. Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension

Exclusion Criteria:

  1. Patients with any form of glaucoma other than open-angle glaucoma.
  2. Patients with a central cornea thickness greater than 620 μm
  3. Patients with Shaffer angle Grade < 2
  4. Patients with a cup/disc ratio greater than 0.80
  5. Patients with severe central visual field loss
  6. Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent)
  7. Chronic, recurrent or severe inflammatory eye disease
  8. Clinically significant or progressive retinal disease
  9. Other ocular pathology
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01452009    
Other Study ID Numbers: C-10-151
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012
Keywords provided by Alcon Research:
open angle glaucoma
ocular hypertension
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Travoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents