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NCT00637130 Clinical Trial

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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00637130
Other study ID # C-06-11
Secondary ID
Status Completed
Phase Phase 2
First received February 29, 2008
Last updated December 4, 2012
Start date October 2007

Study information
Verified date December 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 138
Est. completion date
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Travoprost ophthalmic solution, 0.0008%

• Travoprost ophthalmic solution, 0.001%

• Travoprost ophthalmic solution, 0.0012%

• TRAVATAN

Other:
• Vehicle

Locations
Country Name City State
United States Contact Alcon Call Center at 1-888-451-3937 Fort Worth Texas

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Intraocular Pressure Up to 2 weeks No
See also
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Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
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