Travoprost Five Day Posology Study

This study has been completed.

Sponsor:

Information provided by:

Alcon Research

ClinicalTrials.gov Identifier:

NCT01114893

First received: April 30, 2010

Last updated: May 26, 2011

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 30, 2010
Last Updated Date	May 26, 2011
Start Date ^ICMJE	April 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 26, 2011)	Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5 [ Time Frame: 5 days ] [ Designated as safety issue: No ] Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment
Original Primary Outcome Measures ^ICMJE (submitted: April 30, 2010)	Mean Intraocular Pressure (IOP) change from baseline at 8 AM on Day 5 [ Time Frame: 5 days ] [ Designated as safety issue: No ] Mean IOP change from baseline at 8 PM on Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01114893 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 26, 2011)	IOP Change From Baseline at 8 PM on Day 5 [ Time Frame: 5 Days ] [ Designated as safety issue: No ] Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Travoprost Five Day Posology Study
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Open-angle Glaucoma (OAG) Ocular Hypertension
Intervention ^ICMJE	Drug: Travoprost 0.004% 1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days Drug: Travoprost Vehicle 1 drop in each eye 8 times daily for 5 days Drug: Travoprost (Groups A, B and C) 1 drop in each eye 8 times daily for 5 days
Study Arm (s)	Active Comparator: TRAVATAN TRAVATAN 0.004% once daily Intervention: Drug: Travoprost 0.004% Placebo Comparator: Travoprost Vehicle Travoprost Vehicle Intervention: Drug: Travoprost Vehicle Experimental: Travoprost Group A Travoprost Group A Intervention: Drug: Travoprost (Groups A, B and C) Experimental: Travoprost Group B Travoprost Group B Intervention: Drug: Travoprost (Groups A, B and C) Experimental: Travoprost Group C Travoprost Group C Intervention: Drug: Travoprost (Groups A, B and C)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	Not Provided
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: either sex and any race/ethnicity, ≥18 years old diagnosed with open-angle glaucoma, and/or ocular hypertension meets the following IOP entry criteria: Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1 Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1 satisfies all informed consent requirements; able to read, sign and date the informed consent Exclusion Criteria: females of childbearing potential not meeting protocol conditions angle grade less than Grade 2 in either eye cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye severe central visual field loss in either eye any abnormality preventing reliable applanation tonometry in either eye hypersensitivity to prostaglandin analogues or to any component of the study medication
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01114893
Other Study ID Numbers ^ICMJE	C-09-075
Has Data Monitoring Committee	No
Responsible Party	Matt Walker, PhD, Alcon Research, Ltd
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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