Efficacy Study of Travoprost APS Versus TRAVATAN

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

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution; Drug: Travoprost 0.004% (BAK-preserved) Eye Drops, Solution

• Study Type: Interventional
• Enrollment (Actual): 371
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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; and ≥ 21 and ≤ 36 mmHg at 11 AM & 4 PM.

• Other protocol-defined inclusion criteria may apply.

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 all IOP-lowering medications 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.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRAVATAN APS; One drop once daily in the evening for 3 months	Drug: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution; One drop once daily in the evening for 3 months
Active Comparator: TRAVATAN; One drop once daily in the evening for 3 months	Drug: Travoprost 0.004% (BAK-preserved) Eye Drops, Solution; One drop once daily in the evening for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Intraocular Pressure at 9:00 am	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	3 months (measured at 9:00 am)
Mean Intraocular Pressure at 11:00 am	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	3 months (measured at 11:00 am)
Mean Intraocular Pressure at 4:00 pm	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	3 months (measured at 4:00 pm)

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: February 19, 2009
• First Submitted That Met QC Criteria: February 19, 2009
• First Posted (Estimate): February 20, 2009

Study Record Updates

• Last Update Posted (Estimate): April 6, 2012
• Last Update Submitted That Met QC Criteria: April 4, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: OAG; OHT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost
• Other Study ID Numbers: C-08-40; 2008-006027-31 (EudraCT Number)