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

This study has been withdrawn prior to enrollment.
(Management Decision)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01452009
First received: October 12, 2011
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Three Month Safety and Efficacy Study of TRAVATAN® vs Travoprost Ophthalmic Solution, 0.004%

Resource links provided by NLM:


Further study details as provided by Alcon Research:

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

Enrollment: 0
Study Start Date: November 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01452009     History of Changes
Other Study ID Numbers: C-10-151
Study First Received: October 12, 2011
Last Updated: February 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
open angle glaucoma
ocular hypertension

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Travoprost
Cloprostenol
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014