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NCT00444665 Clinical Trial

Examining The Efficacy, Safety And Improved Tolerability Of Travoprost BAK Free Ophthalmic Solution (Travatan-Z) Compared To Prior Prostaglandin Therapy

Glaucoma Clinical Trial

Official title:
Examining The Efficacy, Safety And Improved Tolerability Of Travoprost BAK Free Ophthalmic Solution (Travatan-Z) Compared To Prior Prostaglandin Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00444665
Other study ID # SMA-06-24
Secondary ID
Status Completed
Phase Phase 4
First received March 7, 2007
Last updated November 18, 2016
Start date May 2007
Est. completion date August 2007

Study information
Verified date April 2008
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Examine the safety, tolerability and efficacy of travoprost benzalkonium chloride (BAK) free ophthalmic solution compared to either latanoprost or bimatoprost monotherapy.

Recruitment information / eligibility
Status Completed
Enrollment 750
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults with a clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye (study eye)

Exclusion Criteria:

- Age

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Travatan-Z

Locations
Country Name City State
United States Fridley Fridley Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Henry JC, Peace JH, Stewart JA, Stewart WC. Efficacy, safety, and improved tolerability of travoprost BAK-free ophthalmic solution compared with prior prostaglandin therapy. Clin Ophthalmol. 2008 Sep;2(3):613-21. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular Surface Disease Symptoms
Secondary Intraocular pressure
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