Efficacy of Changing to TRAVATAN® From Prior Therapy

Multi-Center Study Comparing Efficacy and Tolerability of TRAVATAN® BAK-free (0.004% Travoprost) in Patients Previously on Latanoprost Ophthalmic Solution 0.005% Monotherapy

The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to tolerability issues.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 191
• 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;
• On latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the investigator;
• Intraocular pressure (IOP) <30 millimeters of mercury (mmHg) in both eyes while on latanoprost ophthalmic solution 0.005% monotherapy;
• 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;
• Able to follow instructions and willing and able to attend all study visits;
• Best corrected Snellen visual acuity of 6/60 (20/200; 1.0 LogMAR) or better in each eye;
• Must sign an informed consent form;
• 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;
• Corneal dystrophies in either eye;
• Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye;
• Any clinically significant, serious, or severe medical condition;
• Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study;
• Severe dry eye or keratoconjunctivitis sicca which has been or is currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids;
• Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the 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, or not using reliable means of birth control;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• 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% BAK-free, 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% BAK-free; Containing Polyquad (PQ) preservative; Other Names: TRAVATAN® BAK-free

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Subjects Who Reach Target IOP (≤18 mmHg)	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: Adriana S. Bonadia, Alcon Research

Publications and helpful links

General Publications

• Lopes JF, Hubatsch DA, Amaris P. Effect of benzalkonium chloride-free travoprost on intraocular pressure and ocular surface symptoms in patients with glaucoma previously on latanoprost: an open-label study. BMC Ophthalmol. 2015 Nov 12;15:166. doi: 10.1186/s12886-015-0151-7.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: January 11, 2012
• First Submitted That Met QC Criteria: January 11, 2012
• First Posted (Estimate): January 13, 2012

Study Record Updates

• Last Update Posted (Estimate): June 13, 2014
• Last Update Submitted That Met QC Criteria: May 15, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Open-angle glaucoma; Ocular hypertension; Vascular Diseases; Cardiovascular Diseases; Hypertension; Eye Diseases; Glaucoma; Pharmacologic Actions; Therapeutic Uses; Antihypertensive Agents; Cardiovascular Agents; Travoprost
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Travoprost
• Other Study ID Numbers: RDG-10-300