Text Size

Travoprost 3-Month Safety and Efficacy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01453855
First received: October 13, 2011
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to determine the safety and efficacy of a new travoprost formulation administered once daily for 3 months.


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
 Drug: Travoprost (New Formulation)
Drug: TRAVATAN
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Travoprost
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • IOP Measurement in mmHg at Week 2, Week 6, and Month 3 for each time point (8 AM, 10 AM and 4 PM) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Intraocular Pressure (IOP) will be measured in mmHg at each time point and compared to the baseline IOP. IOP change from baseline, IOP percent change from baseline and percentage of patients with IOP < 18 mmHg at each on-therapy visit (Week 2, Week 6, and Month 3) and time point (8 AM, 10 AM and 4 PM).


Enrollment: 1099
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm 1
Travoprost (New Formulation)
 Drug: Travoprost (New Formulation)
Travoprost new formulation, one drop once daily
Active Comparator: Treatment Arm 2
TRAVATAN
 Drug: TRAVATAN
TRAVATAN

  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. Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.

  3. Qualifying mean IOP (after washout) at both the Eligibility 1 and 2 Visits in at least 1 eye (the same eye) must be:

    • ≥ 24 mmHg at the 8 AM (± 30 minutes) time point and,
    • ≥ 21 mmHg at the 10 AM (± 30 minutes) and 4 PM (± 30 minutes) time points.
  4. Must be able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Independent Ethics Committee.

Exclusion Criteria:

  1. Females of childbearing potential not meeting protocol conditions
  2. Angle grade less than Grade 2 in either eye
  3. Cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
  4. Severe central visual field loss in either eye
  5. Chronic, recurrent or severe inflammatory eye disease
  6. Any abnormality preventing reliable applanation tonometry in either eye
  7. Patients with a central cornea thickness greater than 620 μm
  8. Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent)
  9. Hypersensitivity to prostaglandin analogs or any component of the study medication
  10. 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: NCT01453855

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
ClinicalTrials.gov Identifier: NCT01453855     History of Changes
Other Study ID Numbers: C-11-034
Study First Received: October 13, 2011
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Alcon Research:
open angle glaucoma
ocular hypertension

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

ClinicalTrials.gov processed this record on June 17, 2013