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Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00670033
Recruitment Status : Completed
First Posted : May 1, 2008
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE April 29, 2008
First Posted Date  ICMJE May 1, 2008
Last Update Posted Date July 10, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2014)
Mean change from baseline in intraocular pressure (IOP) [ Time Frame: Baseline, Up to Week 4 ]
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2008)
Mean IOP [ Time Frame: from baseline ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2014)
  • Mean intraocular pressure [ Time Frame: Baseline, Up to Week 4 ]
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage).
  • Mean percent change from baseline in IOP [ Time Frame: Baseline, Up to Week 4 ]
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change indicates a greater amount of improvement.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title  ICMJE Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
Brief Summary The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Ocular Hypertension
  • Open-angle Glaucoma
Intervention  ICMJE
  • Drug: Travoprost ophthalmic solution (new formulation)
  • Drug: Travoprost ophthalmic solution, 0.004%
    Other Names:
    • TRAVATAN®
    • TRAVATAN Z®
  • Drug: Vehicle
    Inactive ingredients used as a placebo
Study Arms  ICMJE
  • Experimental: Travoprost new formulation
    Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
    Intervention: Drug: Travoprost ophthalmic solution (new formulation)
  • Active Comparator: TRAVATAN
    Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
    Intervention: Drug: Travoprost ophthalmic solution, 0.004%
  • Placebo Comparator: Vehicle
    Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2014)
158
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2008)
150
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Satisfy all informed consent requirements;
  • Diagnosed with open-angle glaucoma or ocular hypertension;
  • Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;
  • IOP measurements in at least 1 eye as specified in protocol;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
  • Any form of glaucoma other than open-angle glaucoma;
  • Severe central visual field loss in either eye;
  • Chronic, recurrent or severe inflammatory eye disease;
  • Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;
  • Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR);
  • Intraocular surgery within the past 6 months;
  • Ocular laser surgery within the past 3 months;
  • Any abnormality preventing reliable applanation tonometry;
  • Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study;
  • Other protocol-specified exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00670033
Other Study ID Numbers  ICMJE C-07-46
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Theresa Landry, PhD Alcon Research
PRS Account Alcon Research
Verification Date June 2014

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