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Safety and Intraocular Pressure (IOP) Lowering Efficacy of Low Dose Travoprost

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00637130
First received: February 29, 2008
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to compare the safety and IOP-lowering efficacy of various low dose travoprost formulations in patients with open-angle glaucoma or ocular hypertension.


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
 Drug: Travoprost ophthalmic solution, 0.0008%
Drug: Travoprost ophthalmic solution, 0.001%
Drug: Travoprost ophthalmic solution, 0.0012%
Drug: TRAVATAN
Other: Vehicle
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and IOP Lowering Efficacy of Low Dose Travoprost Ophthalmic Solutions Dosed BID Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension

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:
  • Mean Intraocular Pressure [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: October 2007
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Travoprost 0.0008%
Travoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
 Drug: Travoprost ophthalmic solution, 0.0008%
Experimental: Travoprost 0.001%
Travoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
 Drug: Travoprost ophthalmic solution, 0.001%
Experimental: Travoprost 0.0012%
Travoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
 Drug: Travoprost ophthalmic solution, 0.0012%
Active Comparator: TRAVATAN + Vehicle
TRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks
 Drug: TRAVATAN Other: Vehicle
Placebo Comparator: Vehicle
Vehicle, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
 Other: Vehicle

  Eligibility

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

Inclusion Criteria:

  • Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Age related
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637130

Locations
United States, Texas
Contact Alcon Call Center at 1-888-451-3937
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00637130     History of Changes
Other Study ID Numbers: C-06-11
Study First Received: February 29, 2008
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013