Efficacy Study of Travoprost APS Versus TRAVATAN - Full Text View

Sponsor:	Alcon Research
Information provided by (Responsible Party):	Alcon Research
ClinicalTrials.gov Identifier:	NCT00848536

Purpose

A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension

Condition	Intervention	Phase
Open Angle Glaucoma Ocular Hypertension	Drug: Travoprost APS Drug: TRAVATAN	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Travoprost

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Efficacy: Mean Intraocular Pressure (IOP-measured at 9:00 am) [ Time Frame: 3 months (measured at 9:00 am) ] [ Designated as safety issue: No ]
For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg

All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.

Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Efficacy: Mean Intraocular Pressure (IOP-measured at 11:00 am) [ Time Frame: 3 months (measured at 11:00 am) ] [ Designated as safety issue: No ]
For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg

All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.

Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Efficacy: Mean Intraocular Pressure (IOP-measured at 4:00 pm) [ Time Frame: 3 months (measured at 4:00 pm) ] [ Designated as safety issue: No ]
For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg

All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.

Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis

Enrollment:	371
Study Start Date:	March 2009
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Travoprost APS	Drug: Travoprost APS Travoprost APS 0.004% Eye Drops, Solution, one drop in each eye,once daily
Active Comparator: 2 TRAVATAN	Drug: TRAVATAN Travatan 0.004% Eye Drops, Solution, one drop in each eye, once daily

Eligibility

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

Criteria

Inclusion Criteria:

18 years of age or older, either gender and any race
Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy.
All patients: Mean IOP in same eye (at both Eligibility 1 & 2 Visits)
- 24 and ≤ 36 mmHg at 9 AM
- 21 and ≤ 36 mmHg at 11 AM & 4 PM

Exclusion Criteria:

Females of childbearing potential not meeting conditions set in the protocol.
Severe central visual field loss
Angle Shaffer grade < 2
Cup/disc ratio > 0.8 (horizontal or vertical measurement)
Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
Intraocular surgery or trauma within last 6 months
Any abnormality preventing reliable applanation tonometry
History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study
Allergy/hypersensitivity to study medications
Unable to discontinue use of interocular hypertension (IOP).
lowering medication for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit
Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP.
Use of any additional topical or systemic ocular hypotensive medication during the study.
Therapy with another investigational agent within 30 days prior to the Screening visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848536

Locations

United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00848536 History of Changes
Other Study ID Numbers:	C-08-40, Eudract number: 2008-006027-31
Study First Received:	February 19, 2009
Results First Received:	February 14, 2011
Last Updated:	January 12, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

OAG
OHT

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases

Cardiovascular Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012