Efficacy of Changing to TRAVATAN® From Prior Therapy

Multi-Center Study Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (0.004% Travoprost) in Patients Previously on Latanoprost 0.005% or Bimatoprost 0.01% Ophthalmic Solution Monotherapy

The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® Solution without benzalkonium chloride (BAK) in patients previously on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004%

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye.
• Be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK-containing generics) for at least four weeks prior to Screening visit.
• Would benefit from a switch to TRAVATAN® Solution without BAK containing Polyquad® Preservative due to tolerability issues, in the opinion of the investigator.
• IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period.
• Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
• Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator.
• Any abnormality preventing reliable applanation tonometry in either eye.
• Severe dry eye or related which has been or currently is being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
• Any clinically significant, serious, or severe medical condition.
• Intraocular conventional surgery or laser surgery in either eye less than three months prior to Screening Visit.
• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
• Progressive retinal or optic nerve disease from any cause.
• Women who are pregnant, lactating.
• Women not using reliable means of birth control.
• Use of any systemic medication known to affect IOP which has not been on stable course for at least 7 days prior to Screening Visit.
• Any clinically significant, serious, or severe medical condition.
• Participation in any other investigational study within 30 days of Screening Visit.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRAVATAN® BAK-free; Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks	Drug: Travoprost 0.004%; Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative; Other Names: TRAVATAN® BAK-free

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.	Week 12

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Severine Durier, Pharm.D, Alcon Research

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: December 14, 2011
• First Submitted That Met QC Criteria: December 14, 2011
• First Posted (Estimate): December 16, 2011

Study Record Updates

• Last Update Posted (Estimate): May 19, 2014
• Last Update Submitted That Met QC Criteria: May 9, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Glaucoma; OAG; OHT
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Antihypertensive Agents; Travoprost
• Other Study ID Numbers: RDG-10-298; 2011-000161-13 (EudraCT Number)