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
  Purpose

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.


Condition Intervention Phase
Ocular Hypertension
Open-angle Glaucoma
Drug: Travoprost ophthalmic solution (new formulation)
Drug: Travoprost ophthalmic solution, 0.004%
Drug: Vehicle
Phase 2

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: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 158
Study Start Date: April 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Drug: Travoprost ophthalmic solution, 0.004%
Other Names:
  • TRAVATAN®
  • TRAVATAN Z®
Placebo Comparator: Vehicle
Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Drug: Vehicle
Inactive ingredients used as a placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670033

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Theresa Landry, PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00670033     History of Changes
Other Study ID Numbers: C-07-46
Study First Received: April 29, 2008
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
IOP
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