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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00670033
First received: April 29, 2008
Last updated: July 9, 2014
Last verified: June 2014

April 29, 2008
July 9, 2014
April 2008
September 2008   (final data collection date for primary outcome measure)
Mean change from baseline in intraocular pressure (IOP) [ Time Frame: Baseline, Up to Week 4 ] [ Designated as safety issue: No ]
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.
Mean IOP [ Time Frame: from baseline ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00670033 on ClinicalTrials.gov Archive Site
  • Mean intraocular pressure [ Time Frame: Baseline, Up to Week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Ocular Hypertension
  • Open-angle Glaucoma
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
September 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00670033
C-07-46
No
Alcon Research
Alcon Research
Not Provided
Study Director: Theresa Landry, PhD Alcon Research
Alcon Research
June 2014

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